اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
COZAAR از شرکت ORGANON
New Drug Application (NDA): 020386
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COZAAR | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| COZAAR | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| COZAAR | LOSARTAN POTASSIUM | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/1995 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020386Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/12/2018 | SUPPL-62 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020386Orig1s062Ltr.pdf |
||
| 09/29/2014 | SUPPL-61 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf |
||
| 01/17/2014 | SUPPL-60 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_replace.pdf |
||
| 02/20/2014 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2013 | SUPPL-58 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf |
||
| 09/28/2012 | SUPPL-57 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf |
||
| 11/17/2011 | SUPPL-56 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf |
||
| 12/11/2015 | SUPPL-54 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf |
||
| 06/10/2011 | SUPPL-53 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
|
| 09/23/2010 | SUPPL-52 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020386s052ltr.pdf |
||
| 06/05/2009 | SUPPL-49 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020386s049ltr.pdf |
||
| 09/21/2006 | SUPPL-46 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf |
|
| 08/29/2006 | SUPPL-45 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s045ltr.pdf |
||
| 09/21/2006 | SUPPL-43 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf |
|
| 03/31/2006 | SUPPL-42 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s042ltr.pdf |
|
| 04/12/2005 | SUPPL-40 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf |
||
| 04/12/2005 | SUPPL-39 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf |
||
| 03/25/2003 | SUPPL-32 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-386s032_Cozaar.cfm |
||
| 10/23/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/2004 | SUPPL-29 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm |
||
| 09/17/2002 | SUPPL-28 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-386s028_Cozaar.cfm |
||
| 01/10/2002 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/22/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf |
|
| 03/11/2004 | SUPPL-19 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm |
||
| 01/28/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf |
|
| 06/09/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20386S017_Cozaar.pdf |
|
| 05/13/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386s015_Cozaar.pdf |
|
| 08/31/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/31/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/31/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386-s008_cozaar.pdf |
|
| 11/07/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf |
|
| 02/25/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/29/1995 | SUPPL-1 | Efficacy-Accelerated Approval Confirmatory Study |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/12/2018 | SUPPL-62 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf | |
| 10/12/2018 | SUPPL-62 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf | |
| 12/11/2015 | SUPPL-54 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf | |
| 09/29/2014 | SUPPL-61 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf | |
| 01/17/2014 | SUPPL-60 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf | |
| 01/17/2014 | SUPPL-60 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf | |
| 03/27/2013 | SUPPL-58 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf | |
| 09/28/2012 | SUPPL-57 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf | |
| 11/17/2011 | SUPPL-56 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf | |
| 09/23/2010 | SUPPL-52 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf | |
| 06/05/2009 | SUPPL-49 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf | |
| 08/29/2006 | SUPPL-45 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf | |
| 04/12/2005 | SUPPL-40 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf | |
| 04/12/2005 | SUPPL-39 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf | |
| 03/11/2004 | SUPPL-29 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf | |
| 03/11/2004 | SUPPL-19 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf | |
| 03/25/2003 | SUPPL-32 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf | |
| 09/17/2002 | SUPPL-28 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf |
COZAAR
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COZAAR | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 077424 | SANDOZ |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090544 | UPSHER SMITH LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |
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