Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021319
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVODART DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/20/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen_approv.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/30/2013 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
04/30/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
06/27/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021319s027ltr.pdf
06/09/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
06/09/2011 SUPPL-23 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
09/09/2010 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s022ltr.pdf
06/15/2010 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s018ltr.pdf
03/31/2008 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319s015ltr.pdf
06/19/2008 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319se1-014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-014_SUMR.pdf
12/23/2005 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021319s009rev2.pdf
09/14/2004 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s008ltr.pdf
08/05/2004 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s007ltr.pdf
03/12/2004 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319slr005ltr.pdf
12/31/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/09/2002 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21319se1-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
04/30/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
06/27/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf
06/09/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
06/09/2011 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
09/09/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf
06/15/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf
06/19/2008 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf
03/31/2008 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf
09/14/2004 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf
08/05/2004 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf
10/09/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf
11/20/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf

AVODART

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 204705 BRECKENRIDGE PHARM
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 207935 HAUPT PHARMA
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 203241 MYLAN PHARMS INC
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202530 RISING PHARMS INC
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
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 202204 WEST-WARD PHARMS INT
DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE;ORAL Prescription No AB 204373 ZYDUS PHARMS USA INC

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