Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086468
Company: PARKE DAVIS
Company: PARKE DAVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCAN SR | PROCAINAMIDE HYDROCHLORIDE | 250MG | 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 |
---|---|---|---|---|---|---|---|
12/11/1979 | 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 |
---|---|---|---|---|---|
03/03/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
01/27/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |