Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072042
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25MG;40MG 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
03/14/1988 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
05/24/2002 SUPPL-12 Labeling

Label is not available on this site.

07/17/2001 SUPPL-11 Labeling

Label is not available on this site.

03/30/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

10/05/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/2000 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/11/1998 SUPPL-6 Labeling

Label is not available on this site.

03/22/1994 SUPPL-5 Labeling

Label is not available on this site.

05/11/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/16/1992 SUPPL-3 Labeling

Label is not available on this site.

01/10/1992 SUPPL-2 Labeling

Label is not available on this site.

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