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
CLOZAPINE از شرکت IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 074949
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLOZAPINE | CLOZAPINE | 12.5MG | TABLET;ORAL | Prescription |
None |
No | No |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/26/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74949ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-84 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-81 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-75 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-74 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-73 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-72 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-69 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-68 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-67 | REMS-Proposal |
Label is not available on this site. |
||
| 09/14/2015 | SUPPL-66 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-65 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2013 | SUPPL-63 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2011 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2011 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2011 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2010 | SUPPL-58 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/08/2009 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 09/23/2008 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 09/02/2008 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 05/28/2008 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 04/28/2005 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/25/2005 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/25/2005 | SUPPL-30 |
Label is not available on this site. |
|||
| 07/29/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/04/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2003 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/31/2003 | SUPPL-19 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOZAPINE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 202873 | ACCORD HLTHCARE |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA LTD |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 203807 | MAYNE PHARMA |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 019758 | HERITAGE LIFE |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 202873 | ACCORD HLTHCARE |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA LTD |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 203807 | MAYNE PHARMA |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 019758 | HERITAGE LIFE |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA LTD |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 203807 | MAYNE PHARMA |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 019758 | HERITAGE LIFE |
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