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Generated: September 26, 2017

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 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-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 NDA: 078690

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078690

Ingredient-typeAmino Acids, Aromatic
Mechanism of ActionDOPA Decarboxylase Inhibitors

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 47335-186-08 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-08)
CARBIDOPA AND LEVODOPA
carbidopa; levodopa
TABLET, ORALLY DISINTEGRATING;ORAL 078690 ANDA Sun Pharma Global FZE 47335-186 47335-186-18 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-18)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Citi
Mallinckrodt
Covington
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Medtronic
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Baxter

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