Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020579
Company: SANOFI
Company: SANOFI
| 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-Package Insert, Labeling-Patient 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf | |
| 07/20/2014 | SUPPL-28 | Labeling-Patient 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 |
| 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 | 202433 | AUROBINDO PHARMA LTD |
| TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE;ORAL | Prescription | No | AB | 211885 | CHARTWELL RX |
| 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 | 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 |