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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075091

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NDA 075091 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 075091
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Mylan
Ingredient:carbidopa; levodopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075091
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 075091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 075091 ANDA Mylan Pharmaceuticals Inc. 0378-0088 N 0378-0088-01
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 075091 ANDA Mylan Pharmaceuticals Inc. 0378-0094 N 0378-0094-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;200MG
Approval Date:Sep 30, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG;100MG
Approval Date:Apr 21, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
AstraZeneca
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Medtronic
Harvard Business School
Chubb
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Johnson and Johnson
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