Application 206433
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 | 50MG | No | No |
| 003 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 100MG | No | No |
| 004 | CLOZAPINE | CLOZAPINE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7087 | CLOZAPINE | CLOZAPINE | Major Pharmaceuticals | ANDA | Current |
| 0904-7088 | CLOZAPINE | CLOZAPINE | Major Pharmaceuticals | ANDA | Current |
| 0904-7089 | CLOZAPINE | CLOZAPINE | Major Pharmaceuticals | ANDA | Current |
| 55154-3568 | CLOZAPINE | CLOZAPINE | Cardinal Health | ANDA | Current |
| 60687-404 | CLOZAPINE | CLOZAPINE | American Health Packaging | ANDA | Current |
| 60687-404 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-404 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-404 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-415 | CLOZAPINE | CLOZAPINE | American Health Packaging | ANDA | Current |
| 60687-415 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-415 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-415 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-426 | CLOZAPINE | CLOZAPINE | American Health Packaging | ANDA | Current |
| 60687-426 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-426 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-426 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-548 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-548 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 60687-548 | Clozapine | Clozapine | American Health Packaging | ANDA | Current |
| 65862-844 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-844 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-844 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-844 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-845 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-845 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-845 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-845 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-846 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-846 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-846 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-846 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-847 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-847 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-847 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-847 | CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3357 | CLOZAPINE | CLOZAPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3391 | CLOZAPINE | CLOZAPINE | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76366 | ORIG | 2023-11-06 |
| 46027 | ORIG | 2016-12-06 |