Details for New Drug Application (NDA): 073618

NDA 073618 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pharmobedient, SCS, Watson Labs, and Zydus Pharms, and is included in twenty-nine 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-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:	Dr Reddys Labs Sa
Ingredient:	carbidopa; levodopa
Patents:	0

Pharmacology for NDA: 073618

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	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8555	0615-8555-39	30 TABLET in 1 BLISTER PACK (0615-8555-39)
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073618	ANDA	Dr. Reddy's Laboratories Inc	75907-022	75907-022-01	100 TABLET in 1 BOTTLE (75907-022-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;100MG
Approval Date:	Aug 28, 1992	TE:	AB	RLD:	No

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