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Details for New Drug Application (NDA): 077645

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NDA 077645 describes ZONISAMIDE, which is a drug marketed by Bionpharma Inc, Zydus Pharms Usa, Sun Pharm Inds (in), Sun Pharm Inds, Wockhardt, Mylan, Ani Pharms Inc, Apotex Inc, Upsher-smith Labs, Dr Reddys Labs Ltd, Mylan Pharms Inc, Roxane, Watson Labs, Glenmark Generics, Invagen Pharms, and Corepharma, and is included in seventeen NDAs. It is available from twenty-eight suppliers. Additional details are available on the ZONISAMIDE profile page.

The generic ingredient in ZONISAMIDE is zonisamide. There are sixteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.

Summary for NDA: 077645

Tradename:
ZONISAMIDE
Applicant:
Dr Reddys Labs Ltd
Ingredient:
zonisamide
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077645

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE
zonisamide
CAPSULE;ORAL 077645 ANDA Dr. Reddy's Laboratories Limited 55111-288 55111-288-01 100 CAPSULE in 1 BOTTLE (55111-288-01)
ZONISAMIDE
zonisamide
CAPSULE;ORAL 077645 ANDA Dr. Reddy's Laboratories Limited 55111-288 55111-288-05 500 CAPSULE in 1 BOTTLE (55111-288-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 22, 2005TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Sep 29, 2006TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Sep 29, 2006TE:RLD: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.

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