APPLICATION
ANDA071388
TYPE
ANDA
ORIGINAL APPROVAL
1987-05-15
LATEST ACTION
2001-08-01
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDE INTENSOLDiscontinued
PROPRANOLOL HYDROCHLORIDE 80MG/ML · CONCENTRATE · ORAL
Approval history
2001-08-01Labeling · Supplement 15AP
2001-02-20Manufacturing (CMC) · Supplement 14AP
2001-02-20Manufacturing (CMC) · Supplement 13AP
1996-08-28Manufacturing (CMC) · Supplement 10AP
1994-01-05Labeling · Supplement 9AP
1991-05-16Labeling · Supplement 8AP
1990-10-09Labeling · Supplement 7AP
1990-03-09Labeling · Supplement 6AP
1990-02-28Manufacturing (CMC) · Supplement 4AP
1990-01-16Labeling · Supplement 5AP
1988-12-21Manufacturing (CMC) · Supplement 2AP
1987-05-15OriginalAP
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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