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Details for New Drug Application (NDA): 079085

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NDA 079085 describes CARBIDOPA, LEVODOPA AND ENTACAPONE, which is a drug marketed by Wockhardt Ltd and Sun Pharma Global and is included in three NDAs. It is available from one supplier. Additional details are available on the CARBIDOPA, LEVODOPA AND ENTACAPONE profile page.

The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE 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 NDA: 079085

Tradename:
CARBIDOPA, LEVODOPA AND ENTACAPONE
Applicant:
Sun Pharma Global
Ingredient:
carbidopa; entacapone; levodopa
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079085

Suppliers and Packaging for NDA: 079085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA, LEVODOPA AND ENTACAPONE
carbidopa; entacapone; levodopa
TABLET;ORAL 079085 ANDA Sun Pharma Global FZE 47335-909 47335-909-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-909-08)
CARBIDOPA, LEVODOPA AND ENTACAPONE
carbidopa; entacapone; levodopa
TABLET;ORAL 079085 ANDA Sun Pharma Global FZE 47335-909 47335-909-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-909-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;200MG;100MG
Approval Date:May 10, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG;200MG;150MG
Approval Date:May 10, 2012TE:ABRLD:No


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