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Details for New Drug Application (NDA): 203042

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NDA 203042 describes RILUZOLE, which is a drug marketed by Apotex Corp, Sun Pharm Inds Ltd, Mylan Pharms Inc, Alkem Labs Ltd, Impax Labs, and Glenmark Generics, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the RILUZOLE profile page.

The generic ingredient in RILUZOLE is riluzole. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the riluzole profile page.

Summary for NDA: 203042

Mylan Pharms Inc
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 203042


Suppliers and Packaging for NDA: 203042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203042 ANDA Mylan Pharmaceuticals Inc. 0378-4145 0378-4145-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4145-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 1, 2013TE:ABRLD:No

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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.