Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084580
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESERPINE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; RESERPINE 25MG;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
05/30/1975 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
02/14/1992 SUPPL-35 Labeling

Label is not available on this site.

01/22/1991 SUPPL-34 Labeling

Label is not available on this site.

03/06/1989 SUPPL-31 Labeling

Label is not available on this site.

06/16/1989 SUPPL-30 Labeling

Label is not available on this site.

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