U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088489
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAN SR PROCAINAMIDE HYDROCHLORIDE 1GM 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
01/16/1985 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-16 Labeling

Label is not available on this site.

03/26/1992 SUPPL-15 Labeling

Label is not available on this site.

11/08/1990 SUPPL-13 Labeling

Label is not available on this site.

01/01/1989 SUPPL-5 Labeling

Label is not available on this site.

Back to Top