Clozapine
- Product NDC
- 0378-3816
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201824
- Marketing category
- ANDA
- Substance
- CLOZAPINE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 0378-3816-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01) | 2023-08-16 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Clozapine | Mylan Pharmaceuticals Inc. | 2025-08-15 | HUMAN PRESCRIPTION DRUG LABEL | 26 |
| Clozapine | Mylan Pharmaceuticals Inc. | 2025-06-01 | HUMAN PRESCRIPTION DRUG LABEL | 24 |