Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204373
Company: CADILA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUTASTERIDE DUTASTERIDE 0.5MG 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
10/04/2017 ORIG-1 Approval

Label is not available on this site.

DUTASTERIDE

CAPSULE;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVODART DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription Yes AB 021319 GLAXOSMITHKLINE
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 206373 ACELLA
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 203118 AMNEAL PHARMS
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 206574 ASCENT PHARMS INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202660 AUROBINDO PHARMA LTD
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 090095 BARR
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 200899 BIONPHARMA INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 204373 CADILA
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 209909 HUMANWELL PURACAP
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 204376 MARKSANS PHARMA
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 204262 STRIDES PHARMA
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202421 VINTAGE

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