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 AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 206433
Company: AUROBINDO PHARMA LTD
| 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 | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLOZAPINE | CLOZAPINE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/29/2016 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206433Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-12 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-9 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-4 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 04/25/2017 | SUPPL-2 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2017 | SUPPL-1 | Labeling-Package Insert |
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; 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 |
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; 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 LTD |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 203807 | MAYNE PHARMA |
| 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 |
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