Details for New Drug Application (NDA): 090324

NDA 090324 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms, 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-two 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-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for 090324

Tradename:	CARBIDOPA AND LEVODOPA
Applicant:	Pharmobedient
Ingredient:	carbidopa; levodopa
Patents:	0

Pharmacology for NDA: 090324

Suppliers and Packaging for NDA: 090324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	090324	ANDA	Mylan Pharmaceuticals Inc.	0378-0085	0378-0085-01	100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;100MG
Approval Date:	Sep 28, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;100MG
Approval Date:	Sep 28, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;250MG
Approval Date:	Sep 28, 2009	TE:		RLD:	No

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