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FDA ANDA · ANDA207769

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA207769
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-24
LATEST ACTION
2024-03-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEPrescription
DUTASTERIDE 0.5MG, TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL

Approval history

2024-03-01Labeling · Supplement 3 · standardAP
2018-05-24UNKNOWN · Original · standardAP
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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