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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 065264

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NDA 065264 describes CEFDINIR, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Lupin, Sandoz, and Teva Pharms, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the CEFDINIR profile page.

The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

Summary for 065264

Tradename:	CEFDINIR
Applicant:	Lupin
Ingredient:	cefdinir
Patents:	0

Pharmacology for NDA: 065264

Suppliers and Packaging for NDA: 065264

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFDINIR	cefdinir	CAPSULE;ORAL	065264	ANDA	A-S Medication Solutions	50090-1033	50090-1033-0	10 CAPSULE in 1 BOTTLE (50090-1033-0)
CEFDINIR	cefdinir	CAPSULE;ORAL	065264	ANDA	A-S Medication Solutions	50090-1033	50090-1033-1	20 CAPSULE in 1 BOTTLE (50090-1033-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	May 19, 2006	TE:	AB	RLD:	No

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