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FDA ANDA · ANDA070305

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS

APPLICATION
ANDA070305
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-18
LATEST ACTION
1998-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-04-28Labeling · Supplement 12AP
1997-01-31Manufacturing (CMC) · Supplement 11AP
1991-05-01Labeling · Supplement 10AP
1991-03-21Labeling · Supplement 9AP
1988-08-02Manufacturing (CMC) · Supplement 8AP
1988-01-13Manufacturing (CMC) · Supplement 7AP
1987-08-07Manufacturing (CMC) · Supplement 5AP
1986-12-24Manufacturing (CMC) · Supplement 4AP
1986-12-24Manufacturing (CMC) · Supplement 2AP
1986-12-24Manufacturing (CMC) · Supplement 3AP
1986-10-10Manufacturing (CMC) · Supplement 1AP
1986-04-18OriginalAP
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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