Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089438
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/23/1987 | 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 |
|---|---|---|---|---|---|
| 03/13/2002 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/09/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/09/2002 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 12/09/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/02/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 06/17/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/25/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/13/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/30/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/22/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |