Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022100
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;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 |
|---|---|---|---|---|---|---|---|
| 09/26/2007 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022100s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100_azor_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2020 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022100s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022100Orig1s039ltr.pdf | |
| 01/05/2017 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022100s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022100Orig1s033ltr.pdf | |
| 11/01/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022100s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s032ltr.pdf | |
| 12/09/2016 | SUPPL-30 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s030ltr.pdf |
| 07/08/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s026ltr.pdf | |
| 07/02/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s025ltr.pdf | |
| 06/13/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s024ltr.pdf | |
| 05/14/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022100s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022100Orig1s022ltr.pdf | |
| 12/11/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s020ltr_r.pdf | |
| 09/28/2012 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s019ltr.pdf | |
| 02/01/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100s016ltr.pdf | |
| 11/02/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s014ltr.pdf | |
| 11/14/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s013ltr.pdf | |
| 05/19/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf | |
| 05/19/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf | |
| 08/07/2008 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022100s003ltr.pdf |
| 05/11/2009 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022100s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022100s039lbl.pdf | |
| 01/05/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022100s033lbl.pdf | |
| 11/01/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022100s032lbl.pdf | |
| 09/23/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf | |
| 07/02/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf | |
| 06/13/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf | |
| 07/03/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022100s022lbl.pdf | |
| 12/11/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf | |
| 09/28/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf | |
| 01/18/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf | |
| 11/14/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf | |
| 11/02/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf | |
| 05/19/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf | |
| 05/19/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf | |
| 05/11/2009 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf | |
| 09/26/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf |
AZOR
TABLET;ORAL; EQ 5MG BASE;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207807 | GLENMARK PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 5MG BASE;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207807 | GLENMARK PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207807 | GLENMARK PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207807 | GLENMARK PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |