FDA Approval for EZETIMIBE AND SIMVASTATIN
$ANIP
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 201890
Company: ANI PHARMS INC
Company: ANI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/26/2017 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/29/2020 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2020 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
EZETIMIBE AND SIMVASTATIN
TABLET;ORAL; 10MG;10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 201890 | ANI PHARMS INC |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | MSD INTL |
TABLET;ORAL; 10MG;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 201890 | ANI PHARMS INC |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | MSD INTL |
TABLET;ORAL; 10MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 201890 | ANI PHARMS INC |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | MSD INTL |
TABLET;ORAL; 10MG;80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 201890 | ANI PHARMS INC |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | MSD INTL |