Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078560
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EZETIMIBE | EZETIMIBE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/26/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078560Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2024 | SUPPL-11 | Labeling-Package Insert, Labeling |
Label is not available on this site. |
||
| 02/16/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
EZETIMIBE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 211550 | ACCORD HLTHCARE |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 209234 | ALKEM LABS LTD |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 208803 | AMNEAL PHARMS CO |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 209838 | AUROBINDO PHARMA |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 078560 | GLENMARK PHARMS LTD |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 210859 | HETERO LABS LTD III |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 207311 | OHM LABS INC |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 215693 | ORIENT PHARMA |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 203931 | SANDOZ |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 210673 | SCIEGEN PHARMS |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 200831 | WATSON LABS INC |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 204331 | ZYDUS PHARMS |
| ZETIA | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021445 | ORGANON |