Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083287
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 250MG CAPSULE;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
06/03/1977 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
07/29/1998 SUPPL-50 Labeling

Label is not available on this site.

02/24/1992 SUPPL-49 Labeling

Label is not available on this site.

01/28/1991 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-45 Labeling

Label is not available on this site.

12/14/1987 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/03/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/03/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

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