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FDA ANDA · ANDA070852
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: ACTAVIS ELIZABETH
APPLICATION
ANDA070852
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 80MG · TABLET · ORAL
Approval history
2002-08-26Labeling · Supplement 17AP
2001-11-02Manufacturing (CMC) · Supplement 14AP
2001-06-13Labeling · Supplement 13AP
1998-08-11Labeling · Supplement 12AP
1996-01-18Manufacturing (CMC) · Supplement 11AP
1991-11-21Labeling · Supplement 10AP
1991-09-18Labeling · Supplement 9AP
1989-08-15Manufacturing (CMC) · Supplement 8AP
1989-08-15Manufacturing (CMC) · Supplement 6AP
1989-08-15Manufacturing (CMC) · Supplement 7AP
1988-11-08Manufacturing (CMC) · Supplement 2AP
1988-11-08Labeling · Supplement 5AP
1988-11-08Manufacturing (CMC) · Supplement 3AP
1987-04-17Manufacturing (CMC) · Supplement 1AP
1986-05-15OriginalAP
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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