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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 065418

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NDA 065418 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

Summary for 065418

Tradename:	CEFDINIR
Applicant:	Anda Repository
Ingredient:	cefdinir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jul 18, 2007	TE:	AB	RLD:	No

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