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Application 202873
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-141 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-141 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-141 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-141 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-142 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-142 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-142 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-142 | Clozapine | clozapine | Accord Healthcare Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44585 | ORIG | 2015-11-30 |
| 10125 | ORIG | 2015-11-30 |