Details for New Drug Application (NDA): 022416
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The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 022416
Tradename: | APTIOM |
Applicant: | Sunovion Pharms Inc |
Ingredient: | eslicarbazepine acetate |
Patents: | 10 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022416
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 022416
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-202 | 63402-202-28 | 4 BLISTER PACK in 1 CARTON (63402-202-28) > 7 TABLET in 1 BLISTER PACK (63402-202-07) |
APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-202 | 63402-202-30 | 30 TABLET in 1 BOTTLE (63402-202-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | Yes | ||||
Patent: | See Plans and Pricing | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES |
Expired US Patents for NDA 022416
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-002 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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