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FDA ANDA · ANDA070851

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA070851
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-15
LATEST ACTION
2002-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2002-08-26Labeling · Supplement 19AP
2001-11-02Manufacturing (CMC) · Supplement 17AP
2001-06-13Labeling · Supplement 16AP
1999-10-04Manufacturing (CMC) · Supplement 15AP
1998-08-11Labeling · Supplement 14AP
1998-06-15Manufacturing (CMC) · Supplement 12AP
1998-06-15Manufacturing (CMC) · Supplement 13AP
1996-01-18Manufacturing (CMC) · Supplement 11AP
1991-11-21Labeling · Supplement 9AP
1991-09-18Labeling · Supplement 8AP
1989-08-15Manufacturing (CMC) · Supplement 6AP
1989-08-15Manufacturing (CMC) · Supplement 7AP
1988-11-08Manufacturing (CMC) · Supplement 2AP
1988-11-08Manufacturing (CMC) · Supplement 5AP
1988-11-08Manufacturing (CMC) · Supplement 3AP
1987-04-17Manufacturing (CMC) · Supplement 1AP
1986-05-15OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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