APPLICATION
ANDA070178
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-13
LATEST ACTION
2015-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 60MG · TABLET · ORAL
Approval history
2015-05-18Labeling · Supplement 52 · standardAP
2008-07-14Labeling · Supplement 39AP
2005-05-03Labeling · Supplement 32AP
2002-06-27Labeling · Supplement 28AP
2001-04-25Manufacturing (CMC) · Supplement 27AP
1999-10-28Labeling · Supplement 26AP
1998-09-08Labeling · Supplement 24AP
1993-02-18Labeling · Supplement 22AP
1991-08-07Manufacturing (CMC) · Supplement 15AP
1991-06-21Labeling · Supplement 19AP
1991-03-21Labeling · Supplement 18AP
1991-01-28Manufacturing (CMC) · Supplement 16AP
1990-06-29Manufacturing (CMC) · Supplement 14AP
1989-05-08Manufacturing (CMC) · Supplement 12AP
1989-05-08Labeling · Supplement 13AP
1989-05-08Labeling · Supplement 11AP
1988-06-03Manufacturing (CMC) · Supplement 10AP
1988-06-03Manufacturing (CMC) · Supplement 9AP
1988-03-25Manufacturing (CMC) · Supplement 7AP
1987-12-22Manufacturing (CMC) · Supplement 5AP
1987-12-22Manufacturing (CMC) · Supplement 6AP
1986-05-13OriginalAP
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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