Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021093
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | 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 |
---|---|---|---|---|---|---|---|
09/05/2000 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21093ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-093_AtacandHCT.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021093s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021093Orig1s021ltr.pdf | |
02/09/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021093Orig1s019ltr.pdf | |
04/26/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021093Orig1s018ltr.pdf | |
02/09/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021093Orig1s016ltr.pdf | |
03/29/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021093s015ltr.pdf | |
06/14/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021093s013ltr.pdf | |
03/11/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf | |
05/16/2008 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021093s008ltr.pdf |
08/17/2006 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021093s006LTR.pdf | |
12/16/2004 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21093s004ltr.pdf |
07/03/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/28/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021093s021lbl.pdf | |
02/09/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf | |
02/09/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf | |
04/26/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf | |
03/29/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf | |
06/14/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf | |
03/11/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf | |
08/17/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf | |
09/05/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf |
ATACAND HCT
TABLET;ORAL; 16MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 32MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 32MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS LIFESCIENCES |