Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088907
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESERPINE AND HYDROFLUMETHIAZIDE HYDROFLUMETHIAZIDE; RESERPINE 50MG;0.125MG 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
09/20/1985 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-5 Manufacturing (CMC)

Label is not available on this site.

03/21/1989 SUPPL-4 Labeling

Label is not available on this site.

10/07/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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