Details for New Drug Application (NDA): 202284
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NDA 202284 describes FELBAMATE, which is a drug marketed by Amneal Pharms, Novitium Pharma, Taro, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the FELBAMATE profile page.
The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 202284
| Tradename: | FELBAMATE |
| Applicant: | Ani Pharms |
| Ingredient: | felbamate |
| Patents: | 0 |
Pharmacology for NDA: 202284
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 202284
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELBAMATE | felbamate | TABLET;ORAL | 202284 | ANDA | ANI Pharmaceuticals, Inc. | 62559-730 | 62559-730-01 | 100 TABLET in 1 BOTTLE (62559-730-01) |
| FELBAMATE | felbamate | TABLET;ORAL | 202284 | ANDA | ANI Pharmaceuticals, Inc. | 62559-731 | 62559-731-01 | 100 TABLET in 1 BOTTLE (62559-731-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 4, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Nov 4, 2015 | TE: | AB | RLD: | No | ||||
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