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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202385

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NDA 202385 describes FELBAMATE, which is a drug marketed by Zydus Pharms Usa Inc, Amneal Pharms, Impax Labs Inc, Taro Pharm, and Alvogen Malta, and is included in six NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the felbamate profile page.

Summary for NDA: 202385

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 202385

Suppliers and Packaging for NDA: 202385

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBAMATE
felbamate
SUSPENSION;ORAL 202385 ANDA Amneal Pharmaceuticals LLC 65162-686 65162-686-88 237 mL in 1 BOTTLE (65162-686-88)
FELBAMATE
felbamate
SUSPENSION;ORAL 202385 ANDA Amneal Pharmaceuticals LLC 65162-686 65162-686-90 473 mL in 1 BOTTLE (65162-686-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength600MG/5ML
Approval Date:Dec 16, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
McKesson
McKinsey
Moodys
Boehringer Ingelheim
Chubb
Teva
Julphar
Cerilliant
Queensland Health

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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