Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087020
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 |
---|---|---|---|---|---|---|---|
07/17/1980 | 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 |
---|---|---|---|---|---|
12/09/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/26/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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11/29/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/12/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |