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FDA ANDA · ANDA070322

PROPRANOLOL HYDROCHLORIDE

Sponsor: INNOGENIX

APPLICATION
ANDA070322
TYPE
ANDA
ORIGINAL APPROVAL
1986-08-04
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 10MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 60MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 20MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 18AP
1998-08-04Labeling · Supplement 19AP
1994-12-23Manufacturing (CMC) · Supplement 17AP
1994-10-11Manufacturing (CMC) · Supplement 16AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 13AP
1991-08-19Manufacturing (CMC) · Supplement 12AP
1991-06-26Labeling · Supplement 11AP
1989-09-07Manufacturing (CMC) · Supplement 10AP
1988-08-16Labeling · Supplement 8AP
1987-12-23Manufacturing (CMC) · Supplement 4AP
1987-12-23Manufacturing (CMC) · Supplement 7AP
1987-12-23Manufacturing (CMC) · Supplement 5AP
1987-03-31Manufacturing (CMC) · Supplement 2AP
1986-08-04OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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