Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMPT PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG PROMPT | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/06/1978 | 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 |
---|---|---|---|---|---|
07/29/2002 | SUPPL-49 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/12/2002 | SUPPL-48 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/28/2000 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/28/2000 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/23/1999 | SUPPL-45 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/20/1999 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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12/09/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/1997 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1993 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1993 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1993 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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07/17/1992 | SUPPL-38 | Labeling |
Label is not available on this site. |
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08/07/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
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06/26/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1987 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1987 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1987 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1987 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |