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Serving leading biopharmaceutical companies globally:

Novartis
Citi
Mallinckrodt
QuintilesIMS
Cantor Fitzgerald
US Department of Justice
UBS
Daiichi Sankyo
Colorcon
Fish and Richardson

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202323

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NDA 202323 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Sun Pharma Global, Actavis Elizabeth, Apotex Inc, Idt Australia Ltd, Mayne Pharma, SCS, and Watson Labs, and is included in twenty-three NDAs. It is available from twenty-nine suppliers. Additional details are available on the CARBIDOPA AND LEVODOPA profile page.

The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 202323
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Accord Hlthcare
Ingredient:carbidopa; levodopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202323
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 202323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 202323 ANDA Accord Healthcare, Inc. 16729-078 16729-078-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-10)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 202323 ANDA Accord Healthcare, Inc. 16729-078 16729-078-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG;100MG
Approval Date:Feb 8, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;200MG
Approval Date:Feb 8, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
Dow
Healthtrust
UBS
Daiichi Sankyo
Fuji
Fish and Richardson
US Department of Justice

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