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Details for New Drug Application (NDA): 202810

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NDA 202810 describes OXTELLAR XR, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OXTELLAR XR profile page.

The generic ingredient in OXTELLAR XR is oxcarbazepine. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for NDA: 202810

Tradename:
OXTELLAR XR
Applicant:
Supernus Pharms
Ingredient:
oxcarbazepine
Patents:7
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 202810

Suppliers and Packaging for NDA: 202810

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXTELLAR XR
oxcarbazepine
TABLET, EXTENDED RELEASE;ORAL 202810 NDA Supernus 17772-121 17772-121-01 100 TABLET in 1 BOTTLE (17772-121-01)
OXTELLAR XR
oxcarbazepine
TABLET, EXTENDED RELEASE;ORAL 202810 NDA Supernus 17772-121 17772-121-10 5 TABLET in 1 BLISTER PACK (17772-121-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Oct 19, 2012TE:RLD:No
Patent:7,722,898Patent Expiration:Apr 13, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,617,600Patent Expiration:Apr 13, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,821,930Patent Expiration:Apr 13, 2027Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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