Application 201824
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOZAPINE | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 12.5MG | No | No |
| 002 | CLOZAPINE | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG | No | No |
| 003 | CLOZAPINE | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG | No | No |
| 004 | CLOZAPINE | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 150MG | No | No |
| 005 | CLOZAPINE | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3813 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3813 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3813 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3813 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3815 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3815 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3815 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3815 | Clozapine | clozapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-212 | Clozapine | clozapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-288 | Clozapine | clozapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-288 | Clozapine | clozapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-288 | Clozapine | clozapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-288 | Clozapine | clozapine | Mylan Institutional Inc. | ANDA | Current |