Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020838
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ATACAND | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ATACAND | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ATACAND | CANDESARTAN CILEXETIL | 32MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/04/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20838ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020838s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020838Orig1s041ltr.pdf | |
| 02/09/2016 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020838Orig1s039ltr.pdf | |
| 04/26/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020838Orig1s038ltr.pdf | |
| 02/21/2013 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020838Orig1s036ltr.pdf | |
| 04/27/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s035ltr.pdf | |
| 06/24/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020838s033ltr.pdf | |
| 04/13/2012 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s032ltr.pdf | |
| 10/22/2009 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020838s031ltr.pdf | |
| 08/17/2006 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020838s026LTR.pdf | |
| 02/22/2005 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20838s024ltr.pdf | |
| 12/16/2004 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20838s023ltr.pdf |
| 05/18/2005 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020838s022ltr.pdf | |
| 04/23/2003 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr019ltr.pdf |
| 01/22/2003 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr017ltr.pdf |
| 11/28/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/13/2002 | SUPPL-15 | Efficacy-Accelerated Approval Confirmatory Study |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20838se4-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20838s015_Atacand.cfm | |
| 10/04/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/2001 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2000 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf |
| 12/08/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/24/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020838s041lbl.pdf | |
| 02/09/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf | |
| 02/06/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf | |
| 04/26/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf | |
| 04/27/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf | |
| 04/13/2012 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf | |
| 06/24/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf | |
| 10/22/2009 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf | |
| 08/17/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf | |
| 05/18/2005 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf | |
| 02/22/2005 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf | |
| 09/13/2002 | SUPPL-15 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf | |
| 06/04/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf |
ATACAND
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 8MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 206233 | PRINSTON INC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 16MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 206233 | PRINSTON INC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 32MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 209119 | ALEMBIC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 206233 | PRINSTON INC |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |