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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203261

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NDA 203261 describes CARBIDOPA, which is a drug marketed by Alvogen Malta, Amerigen Pharms Ltd, Edenbridge Pharms, Novel Labs Inc, Accord Hlthcare, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Sun Pharma Global, Actavis Elizabeth, Apotex Inc, Idt Australia Ltd, Mayne Pharma, SCS, Watson Labs, and Wockhardt Ltd, and is included in twenty-eight NDAs. It is available from six suppliers. Additional details are available on the CARBIDOPA profile page.

The generic ingredient in CARBIDOPA is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for 203261
Applicant:Amerigen Pharms Ltd
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203261
Suppliers and Packaging for NDA: 203261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA carbidopa TABLET;ORAL 203261 ANDA Amerigen Pharmaceuticals Inc. 43975-220 N 43975-220-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 10, 2014TE:ABRLD:No

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