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 BARR LABS INC
Abbreviated New Drug Application (ANDA): 090308
Company: BARR LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription |
AB |
No | No |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription |
AB |
No | Yes |
| CLOZAPINE | CLOZAPINE | 12.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 04/09/2018 | ORIG-2 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090308Orig1s000ltr.pdf |
||
| 11/25/2015 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090308Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-9 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-8 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 04/16/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-3 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 04/09/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CLOZAPINE
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090308 | BARR LABS INC |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 201824 | MYLAN |
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090308 | BARR LABS INC |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 201824 | MYLAN |
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