Live FDA approvals and announcements. https://www.quantisnow.com/news/fda en-us Sun, 15 Nov 2026 06:22:22 GMT Submission status for ALEXION PHARM's drug KLYGEFA (ORIG-1) with active ingredient GEFURULIMAB has changed to 'Approval' on 11/13/2026. Application Category: BLA, Application Number: 761488, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-klygefa-issued-to-alexion-pharm-6790183 https://www.quantisnow.com/insight/fda-approval-for-klygefa-issued-to-alexion-pharm-6790183 Fri, 13 Nov 2026 19:30:46 GMT Submission status for JANSSEN BIOTECH's drug LAZCLUZE (SUPPL-5) with active ingredient LAZERTINIB MESYLATE has changed to 'Approval' on 11/12/2026. Application Category: NDA, Application Number: 219008, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-lazcluze-issued-to-janssen-biotech-6789509 https://www.quantisnow.com/insight/fda-approval-for-lazcluze-issued-to-janssen-biotech-6789509 Fri, 13 Nov 2026 13:27:58 GMT Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA HIVES (SUPPL-53) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 020872, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-hives-issued-to-chattem-sanofi-6786938 https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-hives-issued-to-chattem-sanofi-6786938 Thu, 12 Nov 2026 14:21:38 GMT Submission status for SANOFI AVENTIS US's drug RIFADIN (SUPPL-40) with active ingredient RIFAMPIN has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 050627, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-rifadin-issued-to-sanofi-aventis-us-6786937 https://www.quantisnow.com/insight/fda-approval-for-rifadin-issued-to-sanofi-aventis-us-6786937 Thu, 12 Nov 2026 14:21:38 GMT Submission status for HOSPIRA's drug DEFEROXAMINE MESYLATE (SUPPL-33) with active ingredient DEFEROXAMINE MESYLATE has changed to 'Approval' on 11/09/2026. Application Category: ANDA, Application Number: 076019, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-deferoxamine-mesylate-issued-to-hospira-6786936 https://www.quantisnow.com/insight/fda-approval-for-deferoxamine-mesylate-issued-to-hospira-6786936 Thu, 12 Nov 2026 14:21:38 GMT Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA ALLERGY (SUPPL-53) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 020872, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-allergy-issued-to-chattem-sanofi-6786935 https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-allergy-issued-to-chattem-sanofi-6786935 Thu, 12 Nov 2026 14:21:38 GMT Submission status for RIGEL PHARMS's drug GAVRETO (SUPPL-18) with active ingredient PRALSETINIB has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 213721, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-gavreto-issued-to-rigel-pharms-6786934 https://www.quantisnow.com/insight/fda-approval-for-gavreto-issued-to-rigel-pharms-6786934 Thu, 12 Nov 2026 14:21:38 GMT Submission status for CHATTEM SANOFI's drug ALLEGRA ALLERGY (SUPPL-53) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 020872, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-allegra-allergy-issued-to-chattem-sanofi-6786933 https://www.quantisnow.com/insight/fda-approval-for-allegra-allergy-issued-to-chattem-sanofi-6786933 Thu, 12 Nov 2026 14:21:38 GMT Submission status for CHATTEM SANOFI's drug ALLEGRA HIVES (SUPPL-53) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 11/10/2026. Application Category: NDA, Application Number: 020872, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-allegra-hives-issued-to-chattem-sanofi-6786932 https://www.quantisnow.com/insight/fda-approval-for-allegra-hives-issued-to-chattem-sanofi-6786932 Thu, 12 Nov 2026 14:21:38 GMT Submission status for ACTAVIS LABS FL INC's drug OXCARBAZEPINE (ORIG-1) with active ingredient OXCARBAZEPINE has changed to 'Tentative Approval' on 10/28/2026. Application Category: ANDA, Application Number: 205444, Application Classification: https://www.quantisnow.com/insight/fda-tentative-approval-for-oxcarbazepine-issued-to-actavis-labs-fl-6782410 https://www.quantisnow.com/insight/fda-tentative-approval-for-oxcarbazepine-issued-to-actavis-labs-fl-6782410 Tue, 10 Nov 2026 09:58:40 GMT Submission status for TEVA PHARMACEUTICALS INC's drug OLANZAPINE AND SAMIDORPHAN (ORIG-1) with active ingredient OLANZAPINE, SAMIDORPHAN has changed to 'Tentative Approval' on 10/28/2026. Application Category: ANDA, Application Number: 220379, Application Classification: https://www.quantisnow.com/insight/fda-tentative-approval-for-olanzapine-and-samidorphan-issued-to-teva-6782409 https://www.quantisnow.com/insight/fda-tentative-approval-for-olanzapine-and-samidorphan-issued-to-teva-6782409 Tue, 10 Nov 2026 09:58:40 GMT Submission status for TEVA PHARMS's drug ANASTROZOLE (SUPPL-16) with active ingredient ANASTROZOLE has changed to 'Approval' on 11/09/2026. Application Category: ANDA, Application Number: 078058, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-anastrozole-issued-to-teva-pharms-6782408 https://www.quantisnow.com/insight/fda-approval-for-anastrozole-issued-to-teva-pharms-6782408 Tue, 10 Nov 2026 09:48:09 GMT Submission status for AYTU's drug ZOLPIMIST (SUPPL-13) with active ingredient ZOLPIDEM TARTRATE has changed to 'Approval' on 11/09/2026. Application Category: NDA, Application Number: 022196, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-zolpimist-issued-to-aytu-6782407 https://www.quantisnow.com/insight/fda-approval-for-zolpimist-issued-to-aytu-6782407 Tue, 10 Nov 2026 09:48:09 GMT Submission status for IMPAX PHARMS's drug FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUPPL-4) with active ingredient FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 076298, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-fexofenadine-hydrochloride-and-pseudoephedrine-hydrochloride-issued-to-6782406 https://www.quantisnow.com/insight/fda-approval-for-fexofenadine-hydrochloride-and-pseudoephedrine-hydrochloride-issued-to-6782406 Tue, 10 Nov 2026 09:48:09 GMT Submission status for CHATTEM SANOFI's drug ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (SUPPL-27) with active ingredient FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE has changed to 'Approval' on 11/06/2026. Application Category: NDA, Application Number: 021704, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-allegra-d-24-hour-allergy-and-congestion-issued-6782405 https://www.quantisnow.com/insight/fda-approval-for-allegra-d-24-hour-allergy-and-congestion-issued-6782405 Tue, 10 Nov 2026 09:48:09 GMT Submission status for AMNEAL PHARMS NY's drug ISOTRETINOIN (SUPPL-4) with active ingredient ISOTRETINOIN has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 216097, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-amneal-pharms-ny-6782404 https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-amneal-pharms-ny-6782404 Tue, 10 Nov 2026 09:48:09 GMT Submission status for AMNEAL PHARMS NY's drug ISOTRETINOIN (SUPPL-2) with active ingredient ISOTRETINOIN has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 216097, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-amneal-pharms-ny-6782403 https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-amneal-pharms-ny-6782403 Tue, 10 Nov 2026 09:48:09 GMT Submission status for AMGEN INC's drug KANJINTI (SUPPL-12) with active ingredient TRASTUZUMAB-ANNS has changed to 'Approval' on 11/09/2026. Application Category: BLA, Application Number: 761073, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-kanjinti-issued-to-amgen-inc-6782402 https://www.quantisnow.com/insight/fda-approval-for-kanjinti-issued-to-amgen-inc-6782402 Tue, 10 Nov 2026 09:48:09 GMT Submission status for PFIZER INC's drug HYMPAVZI (SUPPL-8) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 11/06/2026. Application Category: BLA, Application Number: 761369, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-hympavzi-issued-to-pfizer-inc-6780745 https://www.quantisnow.com/insight/fda-approval-for-hympavzi-issued-to-pfizer-inc-6780745 Mon, 09 Nov 2026 15:33:13 GMT Submission status for MERCK SHARP DOHME's drug WELIREG (SUPPL-18) with active ingredient BELZUTIFAN has changed to 'Approval' on 11/06/2026. Application Category: NDA, Application Number: 215383, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-welireg-issued-to-merck-sharp-dohme-6779956 https://www.quantisnow.com/insight/fda-approval-for-welireg-issued-to-merck-sharp-dohme-6779956 Mon, 09 Nov 2026 11:27:46 GMT Submission status for JANSSEN BIOTECH's drug RYBREVANT FASPRO (SUPPL-2) with active ingredient AMIVANTAMAB AND HYALURONIDASE-LPUJ has changed to 'Approval' on 11/05/2026. Application Category: BLA, Application Number: 761433, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-rybrevant-faspro-issued-to-janssen-biotech-6778415 https://www.quantisnow.com/insight/fda-approval-for-rybrevant-faspro-issued-to-janssen-biotech-6778415 Fri, 06 Nov 2026 16:12:49 GMT Submission status for AMGEN INC's drug AMJEVITA (SUPPL-27) with active ingredient ADALIMUMAB-ATTO has changed to 'Approval' on 11/05/2026. Application Category: BLA, Application Number: 761024, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-amjevita-issued-to-amgen-inc-6778049 https://www.quantisnow.com/insight/fda-approval-for-amjevita-issued-to-amgen-inc-6778049 Fri, 06 Nov 2026 12:54:58 GMT Submission status for ADC Therapeutics SA's drug ZYNLONTA (SUPPL-15) with active ingredient LONCASTUXIMAB TESIRINE-LPYL has changed to 'Approval' on 11/04/2026. Application Category: BLA, Application Number: 761196, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-zynlonta-issued-to-adc-therapeutics-sa-6773945 https://www.quantisnow.com/insight/fda-approval-for-zynlonta-issued-to-adc-therapeutics-sa-6773945 Thu, 05 Nov 2026 10:25:40 GMT Submission status for TEVA PHARMS USA INC's drug FLUTICASONE PROPIONATE (ORIG-1) with active ingredient FLUTICASONE PROPIONATE has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 209917, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-fluticasone-propionate-issued-to-teva-pharms-usa-6773910 https://www.quantisnow.com/insight/fda-approval-for-fluticasone-propionate-issued-to-teva-pharms-usa-6773910 Thu, 05 Nov 2026 05:25:57 GMT Submission status for AMNEAL PHARMS's drug MOMETASONE FUROATE (SUPPL-15) with active ingredient MOMETASONE FUROATE has changed to 'Approval' on 10/30/2026. Application Category: ANDA, Application Number: 207989, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770894 https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770894 Wed, 04 Nov 2026 10:26:19 GMT Submission status for AMNEAL PHARMS's drug MOMETASONE FUROATE (SUPPL-11) with active ingredient MOMETASONE FUROATE has changed to 'Approval' on 10/30/2026. Application Category: ANDA, Application Number: 207989, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770893 https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770893 Wed, 04 Nov 2026 10:26:19 GMT Submission status for AMNEAL PHARMS's drug MOMETASONE FUROATE (SUPPL-3) with active ingredient MOMETASONE FUROATE has changed to 'Approval' on 10/30/2026. Application Category: ANDA, Application Number: 207989, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770892 https://www.quantisnow.com/insight/fda-approval-for-mometasone-furoate-issued-to-amneal-pharms-6770892 Wed, 04 Nov 2026 10:26:19 GMT Submission status for AMNEAL PHARMS's drug CYCLOPHOSPHAMIDE (ORIG-1) with active ingredient CYCLOPHOSPHAMIDE has changed to 'Approval' on 11/02/2026. Application Category: ANDA, Application Number: 210890, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-cyclophosphamide-issued-to-amneal-pharms-6770891 https://www.quantisnow.com/insight/fda-approval-for-cyclophosphamide-issued-to-amneal-pharms-6770891 Wed, 04 Nov 2026 10:18:44 GMT Submission status for ACTAVIS LABS FL's drug CARBIDOPA AND LEVODOPA (ORIG-1) with active ingredient CARBIDOPA; LEVODOPA has changed to 'Approval' on 11/02/2026. Application Category: ANDA, Application Number: 208522, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-carbidopa-and-levodopa-issued-to-actavis-labs-6770890 https://www.quantisnow.com/insight/fda-approval-for-carbidopa-and-levodopa-issued-to-actavis-labs-6770890 Wed, 04 Nov 2026 10:18:44 GMT Submission status for ACTAVIS LABS FL's drug ISOTRETINOIN (SUPPL-14) with active ingredient ISOTRETINOIN has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 205063, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-actavis-labs-fl-6770889 https://www.quantisnow.com/insight/fda-approval-for-isotretinoin-issued-to-actavis-labs-fl-6770889 Wed, 04 Nov 2026 10:18:44 GMT Submission status for AMNEAL PHARMS's drug GUAIFENESIN (SUPPL-17) with active ingredient GUAIFENESIN has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 207342, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-guaifenesin-issued-to-amneal-pharms-6770888 https://www.quantisnow.com/insight/fda-approval-for-guaifenesin-issued-to-amneal-pharms-6770888 Wed, 04 Nov 2026 10:18:44 GMT Submission status for ACTAVIS ELIZABETH's drug CLONIDINE HYDROCHLORIDE (SUPPL-13) with active ingredient CLONIDINE HYDROCHLORIDE has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 203320, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-clonidine-hydrochloride-issued-to-actavis-elizabeth-6770887 https://www.quantisnow.com/insight/fda-approval-for-clonidine-hydrochloride-issued-to-actavis-elizabeth-6770887 Wed, 04 Nov 2026 10:18:44 GMT Submission status for BAXTER HLTHCARE CORP's drug PROPOFOL (ORIG-1) with active ingredient PROPOFOL has changed to 'Approval' on 11/03/2026. Application Category: ANDA, Application Number: 203421, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-propofol-issued-to-baxter-hlthcare-corp-6770886 https://www.quantisnow.com/insight/fda-approval-for-propofol-issued-to-baxter-hlthcare-corp-6770886 Wed, 04 Nov 2026 10:18:44 GMT Submission status for ETON's drug IMPAVIDO (SUPPL-9) with active ingredient MILTEFOSINE has changed to 'Approval' on 11/02/2026. Application Category: NDA, Application Number: 204684, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-impavido-issued-to-eton-6770636 https://www.quantisnow.com/insight/fda-approval-for-impavido-issued-to-eton-6770636 Tue, 03 Nov 2026 22:51:21 GMT Submission status for GLAXOSMITHKLINE LLC's drug BENLYSTA (SUPPL-38) with active ingredient BELIMUMAB has changed to 'Approval' on 10/30/2026. Application Category: BLA, Application Number: 761043, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-benlysta-issued-to-glaxosmithkline-llc-6770624 https://www.quantisnow.com/insight/fda-approval-for-benlysta-issued-to-glaxosmithkline-llc-6770624 Tue, 03 Nov 2026 22:45:45 GMT Submission status for NOVARTIS's drug LAMPRENE (SUPPL-15) with active ingredient CLOFAZIMINE has changed to 'Approval' on 11/03/2026. Application Category: NDA, Application Number: 019500, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-lamprene-issued-to-novartis-6768506 https://www.quantisnow.com/insight/fda-approval-for-lamprene-issued-to-novartis-6768506 Tue, 03 Nov 2026 13:02:01 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-19) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 10/23/2026. Application Category: BLA, Application Number: 761262, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6756771 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6756771 Mon, 26 Oct 2026 08:47:40 GMT Submission status for AMGEN INC's drug PAVBLU (ORIG-2) with active ingredient AFLIBERCEPT-AYYH has changed to 'Approval' on 10/22/2026. Application Category: BLA, Application Number: 761298, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6756770 https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6756770 Mon, 26 Oct 2026 08:46:40 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-53) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 10/23/2026. Application Category: BLA, Application Number: 761105, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6756769 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6756769 Mon, 26 Oct 2026 08:47:40 GMT Submission status for AMGEN INC's drug PAVBLU (ORIG-2) with active ingredient AFLIBERCEPT-AYYH has changed to 'Approval' on 10/23/2026. Application Category: BLA, Application Number: 761298, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6756192 https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6756192 Fri, 23 Oct 2026 18:59:23 GMT Submission status for CELGENE CORP's drug REBLOZYL (SUPPL-17) with active ingredient LUSPATERCEPT-AAMT has changed to 'Approval' on 10/20/2026. Application Category: BLA, Application Number: 761136, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-reblozyl-issued-to-celgene-corp-6754027 https://www.quantisnow.com/insight/fda-approval-for-reblozyl-issued-to-celgene-corp-6754027 Thu, 22 Oct 2026 08:46:47 GMT Submission status for CELGENE CORP's drug REBLOZYL (SUPPL-17) with active ingredient LUSPATERCEPT-AAMT has changed to 'Approval' on 10/21/2026. Application Category: BLA, Application Number: 761136, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-reblozyl-issued-to-celgene-corp-6753666 https://www.quantisnow.com/insight/fda-approval-for-reblozyl-issued-to-celgene-corp-6753666 Wed, 21 Oct 2026 20:25:53 GMT Submission status for ACADIA PHARMS INC's drug DAYBUE STIX (SUPPL-1) with active ingredient TROFINETIDE has changed to 'Approval' on 10/16/2026. Application Category: NDA, Application Number: 219884, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-daybue-stix-issued-to-acadia-pharms-inc-6749747 https://www.quantisnow.com/insight/fda-approval-for-daybue-stix-issued-to-acadia-pharms-inc-6749747 Mon, 19 Oct 2026 08:59:46 GMT Submission status for AMGEN INC's drug REPATHA (SUPPL-47) with active ingredient EVOLOCUMAB has changed to 'Approval' on 10/09/2026. Application Category: BLA, Application Number: 125522, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6743389 https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6743389 Mon, 12 Oct 2026 08:48:29 GMT Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-5) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-dextroamp-saccharate-amp-aspartate-dextroamp-sulfate-and-6740784 https://www.quantisnow.com/insight/fda-approval-for-dextroamp-saccharate-amp-aspartate-dextroamp-sulfate-and-6740784 Thu, 08 Oct 2026 08:45:39 GMT Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-6) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-dextroamp-saccharate-amp-aspartate-dextroamp-sulfate-and-6740783 https://www.quantisnow.com/insight/fda-approval-for-dextroamp-saccharate-amp-aspartate-dextroamp-sulfate-and-6740783 Thu, 08 Oct 2026 08:45:39 GMT Submission status for ABBVIE INC's drug JUVMO (ORIG-1) with active ingredient TAVAPADON has changed to 'Approval' on 09/25/2026. Application Category: NDA, Application Number: 220415, Application Classification: Type 1 - New Molecular Entity https://www.quantisnow.com/insight/fda-approval-for-juvmo-issued-to-abbvie-inc-6730048 https://www.quantisnow.com/insight/fda-approval-for-juvmo-issued-to-abbvie-inc-6730048 Wed, 30 Sep 2026 12:20:19 GMT Submission status for PFIZER INC's drug RUXIENCE (SUPPL-20) with active ingredient RITUXIMAB-PVVR has changed to 'Approval' on 09/28/2026. Application Category: BLA, Application Number: 761103, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729735 https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729735 Wed, 30 Sep 2026 08:46:04 GMT Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-8) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729734 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729734 Wed, 30 Sep 2026 08:45:36 GMT Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-6) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729733 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729733 Wed, 30 Sep 2026 08:45:36 GMT