Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089369
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 08/14/1987 | 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 |
|---|---|---|---|---|---|
| 05/09/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/23/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/29/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |