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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 073607


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NDA 073607 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from thirty-one 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-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 073607
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Dr Reddys Labs Sa
Ingredient:carbidopa; levodopa
Patents:0
Pharmacology for NDA: 073607
Suppliers and Packaging for NDA: 073607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073607 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8275 0615-8275-39 30 TABLET in 1 BLISTER PACK (0615-8275-39)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073607 ANDA Mayne Pharma Commercial LLC 51862-858 51862-858-01 100 TABLET in 1 BOTTLE (51862-858-01)

Profile for product number 001

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

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