Details for New Drug Application (NDA): 201824
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NDA 201824 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from thirteen suppliers. Additional details are available on the CLOZAPINE profile page.
The generic ingredient in CLOZAPINE 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 CLOZAPINE 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 201824
| Tradename: | CLOZAPINE |
| Applicant: | Mylan |
| Ingredient: | clozapine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201824
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 201824 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3813 | 0378-3813-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01) |
| CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 201824 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3815 | 0378-3815-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 15, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 15, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 7, 2023 | TE: | AB | RLD: | No | ||||
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