Details for New Drug Application (NDA): 212714
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NDA 212714 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, Norvium Bioscience, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm Llc, Amneal Pharms Co, Anda Repository, Apotex, Esjay Pharma, Micro Labs, MSN, Piramal, and Zydus Pharms, and is included in thirty-one NDAs. It is available from nineteen 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-one 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-one suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 212714
| Tradename: | CLOBAZAM |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | clobazam |
| Patents: | 0 |
Pharmacology for NDA: 212714
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 212714
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBAZAM | clobazam | TABLET;ORAL | 212714 | ANDA | Ascend Laboratories, LLC | 67877-664 | 67877-664-01 | 1 BOTTLE in 1 CARTON (67877-664-01) / 100 TABLET in 1 BOTTLE |
| CLOBAZAM | clobazam | TABLET;ORAL | 212714 | ANDA | Ascend Laboratories, LLC | 67877-664 | 67877-664-05 | 500 TABLET in 1 BOTTLE (67877-664-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 6, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Sep 6, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 21, 2020 | TE: | RLD: | No | |||||
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