Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084106
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG 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
08/05/1974 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
12/01/1998 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/30/1995 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/30/1995 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/11/1988 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

03/25/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

03/02/1984 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

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