Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021286
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| BENICAR | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| BENICAR | OLMESARTAN MEDOXOMIL | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/25/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286_Benicar.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2019 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021286s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021286Orig1s040ltr.pdf | |
| 11/01/2016 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021286s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021286Orig1s036ltr.pdf | |
| 07/08/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s032ltr.pdf | |
| 06/27/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s031ltr.pdf | |
| 06/13/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s030ltr.pdf | |
| 07/03/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021286Orig1s027ltr.pdf | |
| 12/11/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s026ltr_r.pdf | |
| 09/28/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s025ltr.pdf | |
| 02/01/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2012 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s023ltr.pdf | |
| 02/15/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s021ltr.pdf | |
| 06/06/2011 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s020ltr.pdf | |
| 05/19/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s019ltr.pdf | |
| 02/04/2010 | SUPPL-18 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021286s018ltr.pdf | |
| 09/26/2007 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021286s012ltr.pdf |
| 07/13/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021286s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021286Orig1s010.pdf | |
| 11/12/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21286s006ltr.pdf |
| 02/12/2003 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21286slr002ltr.pdf |
| 10/25/2002 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/17/2019 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021286s040lbl.pdf | |
| 11/01/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021286s036lbl.pdf | |
| 09/23/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf | |
| 06/27/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf | |
| 06/13/2014 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf | |
| 07/03/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf | |
| 12/11/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf | |
| 09/28/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf | |
| 03/29/2012 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf | |
| 02/15/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf | |
| 06/06/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf | |
| 05/19/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf | |
| 02/04/2010 | SUPPL-18 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf | |
| 07/13/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf | |
| 04/25/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf |
BENICAR
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | COSETTE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | COSETTE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | COSETTE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |