Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090335
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Discontinued | None | No | No |
GABAPENTIN | GABAPENTIN | 800MG | 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 |
---|---|---|---|---|---|---|---|
06/01/2010 | 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 |
---|---|---|---|---|---|
05/23/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/23/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/23/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/23/2023 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/23/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/23/2023 | SUPPL-5 | Labeling-Medication Guide |
Label is not available on this site. |
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05/23/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/29/2012 | SUPPL-3 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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08/04/2011 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |