Details for New Drug Application (NDA): 217482

NDA 217482 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, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Norvium Bioscience, 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-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for 217482

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

Pharmacology for NDA: 217482

Suppliers and Packaging for NDA: 217482

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	217482	ANDA	Advagen Pharma Ltd	72888-155	72888-155-00	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-00)
CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	217482	ANDA	Advagen Pharma Ltd	72888-155	72888-155-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG;100MG
Approval Date:	Jun 4, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG;200MG
Approval Date:	Jun 4, 2024	TE:	AB	RLD:	No

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