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Federal Trade Commission
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078690

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NDA 078690 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-one NDAs. It is available from twenty-five 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078690
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Sun Pharma Global
Ingredient:carbidopa; levodopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078690
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 078690
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078690 ANDA Sun Pharma Global FZE 47335-186 N 47335-186-08
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078690 ANDA Sun Pharma Global FZE 47335-186 N 47335-186-88

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG;100MG
Approval Date:Jul 31, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG;100MG
Approval Date:Jul 31, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG;250MG
Approval Date:Jul 31, 2009TE:ABRLD:No

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