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FDA ANDA · ANDA070947

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: RISING

APPLICATION
ANDA070947
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-01
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 35 · standardAP
2015-06-01Labeling · Supplement 29 · standardAP
2010-08-31Labeling · Supplement 28AP
2004-10-07Labeling · Supplement 17AP
2002-08-20Labeling · Supplement 13AP
2001-10-15Labeling · Supplement 12AP
2001-09-05Manufacturing (CMC) · Supplement 11AP
2000-05-02Manufacturing (CMC) · Supplement 10AP
1998-09-09Labeling · Supplement 9AP
1998-02-25Manufacturing (CMC) · Supplement 7AP
1998-02-05Manufacturing (CMC) · Supplement 8AP
1995-03-01Manufacturing (CMC) · Supplement 6AP
1993-10-06Manufacturing (CMC) · Supplement 5AP
1992-02-05Manufacturing (CMC) · Supplement 3AP
1991-04-04Labeling · Supplement 2AP
1990-01-31Manufacturing (CMC) · Supplement 1AP
1987-04-01OriginalAP
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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