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FDA ANDA · ANDA072043
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: ANI PHARMS
APPLICATION
ANDA072043
TYPE
ANDA
ORIGINAL APPROVAL
1988-03-14
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 17 · standardAP
2020-07-23Labeling · Supplement 16 · standardAP
2002-05-24Labeling · Supplement 12AP
2001-07-17Labeling · Supplement 11AP
2001-03-30Manufacturing (CMC) · Supplement 10AP
2000-10-05Manufacturing (CMC) · Supplement 7AP
2000-10-05Manufacturing (CMC) · Supplement 8AP
2000-07-07Manufacturing (CMC) · Supplement 9AP
1998-08-11Labeling · Supplement 6AP
1994-05-11Manufacturing (CMC) · Supplement 4AP
1994-03-22Labeling · Supplement 5AP
1992-04-16Labeling · Supplement 3AP
1992-01-10Labeling · Supplement 2AP
1988-03-14OriginalAP
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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