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FDA ANDA · ANDA070705

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA070705
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-01
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-08-20Labeling · Supplement 23 · standardAP
2020-07-23Labeling · Supplement 22 · standardAP
1999-12-21Manufacturing (CMC) · Supplement 21AP
1999-05-20Manufacturing (CMC) · Supplement 19AP
1999-04-13Labeling · Supplement 20AP
1998-12-01Manufacturing (CMC) · Supplement 18AP
1994-12-23Manufacturing (CMC) · Supplement 17AP
1994-10-11Manufacturing (CMC) · Supplement 16AP
1994-06-23Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1992-04-03Manufacturing (CMC) · Supplement 12AP
1991-10-28Labeling · Supplement 11AP
1991-09-18Labeling · Supplement 10AP
1987-06-10Manufacturing (CMC) · Supplement 3AP
1987-06-10Manufacturing (CMC) · Supplement 4AP
1987-03-17Manufacturing (CMC) · Supplement 2AP
1987-03-17Manufacturing (CMC) · Supplement 1AP
1986-10-01OriginalAP
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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