Last Updated: November 9, 2026

Details for New Drug Application (NDA): 065337

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NDA 065337 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-six suppliers. Additional details are available on the CEFDINIR profile page.

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

Summary for 065337

Tradename:	CEFDINIR
Applicant:	Chartwell Rx
Ingredient:	cefdinir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Apr 6, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Apr 6, 2007	TE:	AB	RLD:	No

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