Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086065
Company: PARKEDALE
Company: PARKEDALE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAN SR | PROCAINAMIDE HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/22/1995 | 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 |
|---|---|---|---|---|---|
| 05/30/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/03/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/27/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |