Details for New Drug Application (NDA): 201680
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NDA 201680 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 ten 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 201680
| Tradename: | FELBAMATE |
| Applicant: | Amneal Pharms |
| Ingredient: | felbamate |
| Patents: | 0 |
Pharmacology for NDA: 201680
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 201680
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELBAMATE | felbamate | TABLET;ORAL | 201680 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-734 | 53746-734-30 | 30 TABLET in 1 BOTTLE (53746-734-30) |
| FELBAMATE | felbamate | TABLET;ORAL | 201680 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-734 | 53746-734-90 | 90 TABLET in 1 BOTTLE (53746-734-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Sep 13, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Sep 13, 2011 | TE: | AB | RLD: | No | ||||
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