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Generated: September 24, 2017

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Details for New Drug Application (NDA): 078536

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NDA 078536 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Mayne Pharma, Apotex, Apotex Inc, Idt Australia Ltd, Impax Labs, Accord Hlthcare, Mylan, Sun Pharm Inds, Actavis Elizabeth, Kv Pharm, SCS, Watson Labs, and Sun Pharma Global, and is included in twenty-three NDAs. It is available from twenty-nine 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-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 078536

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Antiparkinson Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 078536

Ingredient-type	Amino Acids, Aromatic

Suppliers and Packaging for NDA: 078536

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	078536	ANDA	Lake Erie Medical DBA Quality Care Products LLC	35356-355	35356-355-30	30 TABLET in 1 BOTTLE (35356-355-30)
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	078536	ANDA	Lake Erie Medical DBA Quality Care Products LLC	35356-355	35356-355-60	60 TABLET in 1 BOTTLE (35356-355-60)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;100MG
Approval Date:	Oct 28, 2008	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;100MG
Approval Date:	Oct 28, 2008	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;250MG
Approval Date:	Oct 28, 2008	TE:	AB	RLD:	No

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