Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011971
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORETIC HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Discontinued None No No
ORETIC HYDROCHLOROTHIAZIDE 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
07/06/1959 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/1998 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/14/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/11/1982 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1991 SUPPL-21 Labeling

Label is not available on this site.

06/29/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1976 SUPPL-15 Labeling

Label is not available on this site.

03/03/1975 SUPPL-12 Labeling

Label is not available on this site.

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