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FDA ANDA · ANDA075047

ACEBUTOLOL HYDROCHLORIDE

Sponsor: AMNEAL PHARM

APPLICATION
ANDA075047
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-30
LATEST ACTION
2015-04-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ACEBUTOLOL HYDROCHLORIDEPrescription
ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE · CAPSULE · ORAL
ACEBUTOLOL HYDROCHLORIDEPrescription
ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2015-04-06Labeling · Supplement 7AP
2011-01-21Manufacturing (CMC) · Supplement 9AP
2007-05-22Manufacturing (CMC) · Supplement 4AP
2007-05-22Manufacturing (CMC) · Supplement 5AP
2007-05-22Manufacturing (CMC) · Supplement 3AP
1999-12-30Original — Letter ↗AP
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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