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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207769
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/24/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL; 0.5MG;0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE;ORAL Prescription No AB 202509 ANCHEN PHARMS
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE;ORAL Prescription No AB 207769 ZYDUS PHARMS
JALYN DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE;ORAL Prescription Yes AB 022460 WOODWARD
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