Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077894
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| GABAPENTIN | GABAPENTIN | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/10/2006 | 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 |
|---|---|---|---|---|---|
| 09/16/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/02/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/26/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/26/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/26/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/26/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/17/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/17/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/17/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/11/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |