Details for New Drug Application (NDA): 019758
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NDA 019758 describes CLOZARIL, which is a drug marketed by Heritage Life and is included in one NDA. It is available from one supplier. Additional details are available on the CLOZARIL profile page.
The generic ingredient in CLOZARIL is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
The generic ingredient in CLOZARIL is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 019758
| Tradename: | CLOZARIL |
| Applicant: | Heritage Life |
| Ingredient: | clozapine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019758
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOZARIL | clozapine | TABLET;ORAL | 019758 | NDA | HLS Therapeutics (USA), Inc. | 69809-0126 | 69809-0126-5 | 100 TABLET in 1 BOTTLE (69809-0126-5) |
| CLOZARIL | clozapine | TABLET;ORAL | 019758 | NDA | HLS Therapeutics (USA), Inc. | 69809-0127 | 69809-0127-5 | 100 TABLET in 1 BOTTLE (69809-0127-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 26, 1989 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 26, 1989 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 20, 2019 | TE: | AB | RLD: | Yes | ||||
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