Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202917
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/01/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2024 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 01/03/2024 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |