APPLICATION
ANDA070221
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-14
LATEST ACTION
2012-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 60MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 20MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2012-01-27Labeling · Supplement 23AP
1991-11-13Labeling · Supplement 19AP
1991-02-13Labeling · Supplement 18AP
1989-10-02Bioequivalence · Supplement 21AP
1989-09-06Labeling · Supplement 17AP
1989-07-11Labeling · Supplement 15AP
1988-03-07Manufacturing (CMC) · Supplement 12AP
1988-02-11Manufacturing (CMC) · Supplement 3AP
1988-01-04Manufacturing (CMC) · Supplement 11AP
1988-01-04Manufacturing (CMC) · Supplement 10AP
1987-07-22Manufacturing (CMC) · Supplement 4AP
1987-07-22Manufacturing (CMC) · Supplement 5AP
1986-11-07Manufacturing (CMC) · Supplement 2AP
1986-11-07Manufacturing (CMC) · Supplement 1AP
1986-04-14OriginalAP
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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