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Generated: October 15, 2018

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Details for New Drug Application (NDA): 073618

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NDA 073618 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-three 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-six suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 073618
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Mayne Pharma
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 073618
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 073618
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073618 ANDA Major Pharmaceuticals 0904-7718 0904-7718-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-7718-61)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073618 ANDA Mayne Pharma Inc 51862-077 51862-077-01 100 TABLET in 1 BOTTLE, PLASTIC (51862-077-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;100MG
Approval Date:Aug 28, 1992TE:ABRLD:No

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