Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213469
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
04/24/2020 | 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 |
---|---|---|---|---|---|
09/12/2024 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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10/12/2022 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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10/25/2022 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/02/2020 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |