Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
| 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 | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| CLOZAPINE | CLOZAPINE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/2002 | 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 |
|---|---|---|---|---|---|
| 02/02/2024 | SUPPL-57 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/02/2024 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2021 | SUPPL-55 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-54 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/02/2024 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-50 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/02/2024 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-45 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/29/2017 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2017 | SUPPL-39 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2017 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-36 | REMS-Proposal |
Label is not available on this site. |
||
| 06/26/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/05/2011 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2010 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/17/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/19/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/07/2017 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/30/2006 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/13/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/19/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/19/2005 | SUPPL-5 | Manufacturing (CMC)-New Strength |
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 |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| 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 |
| 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 |
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 |