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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087510
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAN SR PROCAINAMIDE HYDROCHLORIDE 750MG 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-29 Labeling

Label is not available on this site.

06/23/1993 SUPPL-26 Labeling

Label is not available on this site.

03/03/1992 SUPPL-25 Labeling

Label is not available on this site.

06/06/1991 SUPPL-24 Labeling

Label is not available on this site.

01/27/1989 SUPPL-20 Labeling

Label is not available on this site.

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