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Last Updated: November 22, 2024

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, 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 065337

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

Pharmacology for NDA: 065337

Suppliers and Packaging for NDA: 065337

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065337	ANDA	Proficient Rx LP	71205-183	71205-183-60	60 mL in 1 BOTTLE (71205-183-60)

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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