Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084403
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 375MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1977 | 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 |
|---|---|---|---|---|---|
| 07/29/1998 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 02/24/1992 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/01/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 03/07/1988 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1988 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/19/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/21/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |