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FDA ANDA · ANDA203192

ALFUZOSIN HYDROCHLORIDE

Sponsor: UNICHEM

APPLICATION
ANDA203192
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-28
LATEST ACTION
2020-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ALFUZOSIN HYDROCHLORIDEPrescription
ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-09-04Labeling · Supplement 7 · standardAP
2018-12-07Labeling · Supplement 6 · standardAP
2016-01-28UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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