Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084403
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 375MG 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-42 Labeling

Label is not available on this site.

02/24/1992 SUPPL-41 Labeling

Label is not available on this site.

01/28/1991 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-37 Labeling

Label is not available on this site.

03/07/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/07/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/07/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/18/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/28/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/28/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/19/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/09/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/21/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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