Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088850
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROFLUMETHIAZIDE HYDROFLUMETHIAZIDE 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
05/31/1985 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
06/07/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/22/1991 SUPPL-5 Labeling

Label is not available on this site.

03/11/1991 SUPPL-4 Labeling

Label is not available on this site.

11/14/1988 SUPPL-3 Labeling

Label is not available on this site.

09/08/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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