Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084735
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APRESAZIDE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 25MG;25MG 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
05/26/1976 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
07/20/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 SUPPL-34 Labeling

Label is not available on this site.

04/07/1993 SUPPL-33 Labeling

Label is not available on this site.

11/04/1992 SUPPL-32 Labeling

Label is not available on this site.

02/21/1992 SUPPL-31 Labeling

Label is not available on this site.

06/18/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/20/1991 SUPPL-29 Labeling

Label is not available on this site.

11/03/1988 SUPPL-26 Labeling

Label is not available on this site.

02/09/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/06/1989 SUPPL-23 Labeling

Label is not available on this site.

04/30/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/16/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/24/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/24/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/24/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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