Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075417
Company: MYLAN
Company: MYLAN
| 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 | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/1999 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75417ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075417_clozapine_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/10/2021 | SUPPL-51 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-49 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-46 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-41 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/25/2017 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2017 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2017 | SUPPL-38 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-37 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 09/14/2015 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2014 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2013 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2013 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2011 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2010 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2010 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf |
| 04/15/2010 | SUPPL-24 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf |
| 04/08/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/15/2010 | SUPPL-21 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf |
| 11/19/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/31/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/31/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/17/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/12/2001 | SUPPL-1 | Labeling |
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 |