Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/05/2024 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2021 | SUPPL-49 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-47 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/05/2024 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-44 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/05/2024 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-32 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-30 | REMS-Proposal |
Label is not available on this site. |
||
| 09/14/2015 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2011 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2011 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2010 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/23/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/19/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/03/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-4 | Labeling |
Label is not available on this site. |
CLOZAPINE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 200MG | 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 |
| 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 | 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 |
| 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 | 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 |