Last Updated: June 10, 2026

Details for New Drug Application (NDA): 065368

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NDA 065368 describes CEFDINIR, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Chartwell Rx, Lupin, and Teva Pharms, and is included in twelve NDAs. It is available from twenty-five 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-five suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

Summary for 065368

Tradename:	CEFDINIR
Applicant:	Teva Pharms
Ingredient:	cefdinir
Patents:	0

Pharmacology for NDA: 065368

Suppliers and Packaging for NDA: 065368

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFDINIR	cefdinir	CAPSULE;ORAL	065368	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3160	0093-3160-06	60 CAPSULE in 1 BOTTLE (0093-3160-06)
CEFDINIR	cefdinir	CAPSULE;ORAL	065368	ANDA	AvKARE	42291-043	42291-043-60	60 CAPSULE in 1 BOTTLE (42291-043-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	May 9, 2007	TE:	AB	RLD:	No

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