Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209096
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| METRONIDAZOLE | METRONIDAZOLE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/08/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/31/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/29/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |