Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201824
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 12.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | None (Tentative Approval) | None | No | No |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLOZAPINE | CLOZAPINE | 150MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 09/15/2015 | ORIG-2 | Tentative Approval | Not Applicable |
Label is not available on this site. |
|||
| 09/15/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201824Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/13/2025 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/13/2025 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/22/2025 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2021 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/26/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2019 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/17/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2016 | SUPPL-4 | 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 | 212923 | AUROBINDO PHARMA |
| 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 | 212923 | AUROBINDO PHARMA |
| 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 |
TABLET, ORALLY DISINTEGRATING;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 150MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 212923 | AUROBINDO PHARMA |
| CLOZAPINE | CLOZAPINE | 150MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090308 | BARR LABS INC |
| CLOZAPINE | CLOZAPINE | 150MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 201824 | MYLAN |
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 212923 | AUROBINDO PHARMA |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090308 | BARR LABS INC |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 201824 | MYLAN |