Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084503
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;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
11/23/1976 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
07/02/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/03/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/16/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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