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Details for New Drug Application (NDA): 022416

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NDA 022416 describes APTIOM, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the APTIOM profile page.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are six 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 NDA: 022416

Tradename:
APTIOM
Applicant:
Sunovion Pharms Inc
Ingredient:
eslicarbazepine acetate
Patents:3

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 63402-202-30 30 TABLET in 1 BOTTLE (63402-202-30)
APTIOM
eslicarbazepine acetate
TABLET;ORAL 022416 NDA Sunovion Pharmaceuticals Inc. 63402-204 63402-204-28 4 BLISTER PACK in 1 CARTON (63402-204-28) > 7 TABLET in 1 BLISTER PACK (63402-204-07)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 8, 2013TE:RLD:No
Patent:8,372,431Patent Expiration:Apr 17, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:9,206,135Patent Expiration:Apr 21, 2026Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 27, 2018
Regulatory Exclusivity Use:1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE


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