Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088946
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRA-ZIDE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 50MG;50MG CAPSULE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/1985 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
11/26/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/03/1995 SUPPL-16 Labeling

Label is not available on this site.

06/14/1991 SUPPL-15 Labeling

Label is not available on this site.

04/04/1991 SUPPL-14 Labeling

Label is not available on this site.

05/08/1989 SUPPL-12 Labeling

Label is not available on this site.

01/26/1989 SUPPL-11 Labeling

Label is not available on this site.

11/29/1988 SUPPL-10 Labeling

Label is not available on this site.

01/10/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/05/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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