Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089027
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/1985 | 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 |
|---|---|---|---|---|---|
| 06/08/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/30/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/23/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |