Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087361
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRONESTYL-SR | PROCAINAMIDE HYDROCHLORIDE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/12/1981 | 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 |
|---|---|---|---|---|---|
| 12/29/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/02/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/28/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-19 | Bioequivalence |
Label is not available on this site. |
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| 02/07/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 12/01/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/12/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/27/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/19/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/22/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/12/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/15/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |