Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090095
Company: BARR
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
12/21/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090095s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090095Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2015 SUPPL-2 Labeling-Package Insert

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 202808 ACTAVIS LABS FL INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 203118 AMNEAL PHARMS
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 204292 APOTEX INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 206574 ASCENT PHARMS INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202660 AUROLIFE PHARMA LLC
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 207935 HERITAGE PHARMS INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202204 HIKMA
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 209909 HUMANWELL PURACAP
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 206373 INTERGEL PHARMS INC
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 PHARMS LLC

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