Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021176
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/26/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022362s029,021176s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022362Orig1s029,021176Orig1s049ltr.pdf | |
| 07/29/2020 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s028,021176s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022362Orig1s028, 021176Orig1s048ltr.pdf | |
| 05/12/2020 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022362Orig1s027,021176Orig1s047,210895Orig1s001ltr.pdf | |
| 05/21/2019 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s045,022362s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021176Orig1s045, 022362Orig1s025ltr.pdf | |
| 01/16/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s044,022362s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/21176Orig1s044,022362Orig1s023ltr.pdf | |
| 07/14/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf | |
| 01/22/2014 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf | |
| 02/25/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2013 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf | |
| 07/09/2012 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf | |
| 01/03/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf | |
| 07/18/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf | |
| 09/14/2010 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf | |
| 10/02/2009 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf | |
| 05/30/2008 | SUPPL-21 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s021ltr.pdf |
| 08/27/2007 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021176s019ltr.pdf | |
| 01/18/2008 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s017ltr.pdf | |
| 07/10/2006 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s015LTR.pdf | |
| 09/06/2006 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s014_ltr.pdf | |
| 11/17/2003 | SUPPL-10 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs010ltr.pdf | |
| 10/10/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr009ltr.pdf | |
| 08/21/2003 | SUPPL-8 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs008ltr.pdf | |
| 08/08/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21176scp005ltr.pdf | |
| 02/11/2003 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr004ltr.pdf | |
| 05/10/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022362s029,021176s049lbl.pdf | |
| 07/29/2020 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s028,021176s048lbl.pdf | |
| 05/12/2020 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf | |
| 05/21/2019 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s045,022362s025lbl.pdf | |
| 01/16/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s044,022362s023lbl.pdf | |
| 01/22/2014 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf | |
| 06/28/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf | |
| 06/28/2013 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf | |
| 07/09/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf | |
| 01/03/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf | |
| 07/18/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf | |
| 09/14/2010 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf | |
| 10/02/2009 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf | |
| 01/18/2008 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf | |
| 08/27/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf | |
| 09/06/2006 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf | |
| 07/10/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf | |
| 11/17/2003 | SUPPL-10 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf |
| 10/10/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf | |
| 08/21/2003 | SUPPL-8 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf |
| 02/11/2003 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf | |
| 10/17/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf | |
| 05/26/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf |
WELCHOL
TABLET;ORAL; 625MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 209038 | ALKEM LABS LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 206036 | BEIJING TIDE PHARM |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 208670 | BIONPHARMA |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 210889 | DR REDDYS |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 203480 | GLENMARK PHARMS LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 091600 | IMPAX LABS INC |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 212050 | INVENTIA |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 209946 | ZHEJIANG JINGXIN |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 207765 | ZYDUS PHARMS |
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | Yes | AB | 021176 | COSETTE |