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Details for New Drug Application (NDA): 073607

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NDA 073607 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Mayne Pharma, Apotex, Apotex Inc, Idt Australia Ltd, Impax Labs, Accord Hlthcare, Mylan, Sun Pharm Inds, Actavis Elizabeth, Kv Pharm, SCS, Watson Labs, and Sun Pharma Global, and is included in twenty-three NDAs. It is available from twenty-six 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-nine suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 073607

Mayne Pharma
carbidopa; levodopa
Therapeutic Class:Antiparkinson Agents

Pharmacology for NDA: 073607

Mechanism of ActionDOPA Decarboxylase Inhibitors

Suppliers and Packaging for NDA: 073607

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
carbidopa; levodopa
TABLET;ORAL 073607 ANDA Teva Pharmaceuticals USA Inc 0093-0294 0093-0294-01 100 TABLET in 1 BOTTLE (0093-0294-01)
carbidopa; levodopa
TABLET;ORAL 073607 ANDA Teva Pharmaceuticals USA Inc 0093-0294 0093-0294-05 500 TABLET in 1 BOTTLE (0093-0294-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:Aug 28, 1992TE:ABRLD:No

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