APPLICATION
ANDA072499
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-11
LATEST ACTION
1998-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1998-09-30Labeling · Supplement 9AP
1998-06-16Labeling · Supplement 8AP
1998-03-09Manufacturing (CMC) · Supplement 7AP
1998-01-26Labeling · Supplement 6AP
1997-01-31Manufacturing (CMC) · Supplement 5AP
1993-04-23Labeling · Supplement 4AP
1993-02-22Manufacturing (CMC) · Supplement 3AP
1990-11-20Manufacturing (CMC) · Supplement 1AP
1989-04-11OriginalAP
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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