Details for New Drug Application (NDA): 210746
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NDA 210746 describes CLOBAZAM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Amneal Pharms Co, Apotex, Breckenridge, Celltrion, Micro Labs, MSN, Piramal Hlthcare Uk, and Zydus Pharms, and is included in thirty-one NDAs. It is available from twenty-one suppliers. Additional details are available on the CLOBAZAM profile page.
The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.
The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 210746
| Tradename: | CLOBAZAM |
| Applicant: | Vistapharm |
| Ingredient: | clobazam |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210746
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 210746
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBAZAM | clobazam | SUSPENSION;ORAL | 210746 | ANDA | VistaPharm, LLC | 66689-058 | 66689-058-04 | 1 BOTTLE, PLASTIC in 1 CARTON (66689-058-04) / 120 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
| Approval Date: | Jul 10, 2019 | TE: | RLD: | No | |||||
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