Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212198
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Discontinued | None | No | No |
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET;ORAL | Discontinued | None | No | No |
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;500MG | TABLET;ORAL | Discontinued | None | No | No |
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;1GM | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/07/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212198Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2024 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |