Details for New Drug Application (NDA): 073607

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	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8516	0615-8516-39	30 TABLET in 1 BLISTER PACK (0615-8516-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;250MG
Approval Date:	Aug 28, 1992	TE:	AB	RLD:	No

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