Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020579
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOMAX TAMSULOSIN HYDROCHLORIDE 0.4MG 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
04/15/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020579_s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/23/2019 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020579s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020579Orig1s033ltr.pdf
01/21/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/20/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf
07/20/2014 SUPPL-28 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s028ltr.pdf
07/25/2011 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020579s027ltr.pdf
12/22/2009 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s026ltr.pdf
10/29/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s025ltr.pdf
12/02/2008 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s024ltr.pdf
04/29/2008 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s023ltr.pdf
02/16/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s021ltr.pdf
01/11/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s020ltr.pdf
10/18/2005 SUPPL-17 Labeling

Label is not available on this site.

10/18/2005 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020579s016ltr.pdf
12/17/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/06/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/01/2001 SUPPL-7 Labeling

Label is not available on this site.

09/02/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/23/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1998 SUPPL-2 Labeling

Label is not available on this site.

08/25/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/23/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020579s033lbl.pdf
10/20/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf
07/20/2014 SUPPL-28 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf
07/20/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf
07/25/2011 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf
12/22/2009 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf
10/29/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf
02/16/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf
01/11/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf
10/18/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf

FLOMAX

CAPSULE;ORAL; 0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLOMAX TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription Yes AB 020579 SANOFI AVENTIS US
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 207405 ALKEM LABS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 202010 ANCHEN PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 202433 AUROBINDO PHARMA LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090377 IMPAX LABS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 204645 MACLEODS PHARMS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090408 MYLAN
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078015 SANDOZ
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090931 SUN PHARM INDS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078801 SYNTHON PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 077630 TEVA PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078938 WOCKHARDT
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078225 ZYDUS PHARMS USA INC

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