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Generated: February 15, 2019

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Details for New Drug Application (NDA): 078536

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NDA 078536 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, Ani Pharms Inc, Apotex Inc, Mayne Pharma, SCS, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-two 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-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078536
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Sun Pharm Inds
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 078536
Suppliers and Packaging for NDA: 078536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 078536 ANDA Sun Pharmaceutical Industries, Inc. 62756-517 62756-517-08 100 TABLET in 1 BOTTLE (62756-517-08)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 078536 ANDA Sun Pharmaceutical Industries, Inc. 62756-517 62756-517-13 500 TABLET in 1 BOTTLE (62756-517-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;100MG
Approval Date:Oct 28, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Oct 28, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:Oct 28, 2008TE:ABRLD:No

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