Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENYTOIN | PHENYTOIN | 125MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
09/25/1992 | 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 |
---|---|---|---|---|---|
03/10/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/13/2001 | SUPPL-12 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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11/02/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/18/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/18/2000 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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02/09/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/09/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |