Application 074949
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 25MG | No | No |
| 002 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 100MG | No | No |
| 003 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 12.5MG | No | No |
| 004 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4359 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7772 | Clozapine | Clozapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 55154-8285 | Clozapine | Clozapine | Cardinal Health | ANDA | Current |
| 55154-8285 | Clozapine | Clozapine | Cardinal Health | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24050 | ORIG | 2015-09-16 |
| 22390 | ORIG | 1998-01-26 |