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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 065434

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NDA 065434 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 065434

Tradename:	CEFDINIR
Applicant:	Aurobindo Pharma
Ingredient:	cefdinir
Patents:	0

Pharmacology for NDA: 065434

Suppliers and Packaging for NDA: 065434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFDINIR	cefdinir	CAPSULE;ORAL	065434	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-959	43063-959-14	14 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-14)
CEFDINIR	cefdinir	CAPSULE;ORAL	065434	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-959	43063-959-20	20 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jan 7, 2008	TE:	AB	RLD:	No

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