APPLICATION
ANDA071976
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-06
LATEST ACTION
2015-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 60MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
Approval history
2015-01-22Manufacturing (CMC) · Supplement 32AP
2014-12-09Labeling · Supplement 29AP
2008-03-20Labeling · Supplement 23AP
2008-01-07Labeling · Supplement 24AP
2002-05-24Labeling · Supplement 11AP
2001-06-08Manufacturing (CMC) · Supplement 10AP
2000-07-07Manufacturing (CMC) · Supplement 9AP
1999-11-22Labeling · Supplement 8AP
1999-06-10Labeling · Supplement 7AP
1998-10-20Labeling · Supplement 6AP
1994-05-11Manufacturing (CMC) · Supplement 5AP
1992-04-23Labeling · Supplement 4AP
1991-10-24Labeling · Supplement 3AP
1988-08-30Manufacturing (CMC) · Supplement 1AP
1988-04-06OriginalAP
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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