Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070852
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25MG;80MG 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
05/15/1986 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
08/26/2002 SUPPL-17 Labeling

Label is not available on this site.

11/02/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/2001 SUPPL-13 Labeling

Label is not available on this site.

08/11/1998 SUPPL-12 Labeling

Label is not available on this site.

01/18/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-10 Labeling

Label is not available on this site.

09/18/1991 SUPPL-9 Labeling

Label is not available on this site.

08/15/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/15/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/15/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/08/1988 SUPPL-5 Labeling

Label is not available on this site.

11/08/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/08/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/17/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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