APPLICATION
ANDA070213
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-19
LATEST ACTION
2021-06-07
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 40MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2021-06-07Labeling · Supplement 36 · standardAP
2004-11-05Labeling · Supplement 23AP
2002-04-03Labeling · Supplement 20AP
1999-11-24Labeling · Supplement 19AP
1998-08-10Labeling · Supplement 18AP
1998-02-25Manufacturing (CMC) · Supplement 17AP
1998-02-05Manufacturing (CMC) · Supplement 16AP
1993-11-16Manufacturing (CMC) · Supplement 15AP
1992-01-02Manufacturing (CMC) · Supplement 13AP
1991-07-16Labeling · Supplement 12AP
1990-08-23Labeling · Supplement 11AP
1990-05-11Labeling · Supplement 10AP
1989-08-07Manufacturing (CMC) · Supplement 9AP
1989-08-07Manufacturing (CMC) · Supplement 7AP
1989-06-12Labeling · Supplement 49AP
1989-06-12Labeling · Supplement 8AP
1989-06-01Labeling · Supplement 6AP
1987-02-20Manufacturing (CMC) · Supplement 3AP
1986-06-19Manufacturing (CMC) · Supplement 1AP
1985-11-19OriginalAP
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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