Details for New Drug Application (NDA): 021530

NDA 021530 describes MELOXICAM, which is a drug marketed by Lupin Ltd, Novitium Pharma, Avondale Pharms, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cipla, Corepharma, Cr Double Crane, Glenmark Pharms Ltd, Impax Labs Inc, Lupin Pharms, Mylan, Natco Pharma, Puracap Pharm, Rising, Roxane, Sun Pharm Inds Inc, Taro, Tp Anda Holdings, Unichem, Yabao Pharm, Yung Shin Pharm, and Zydus Pharms Usa, and is included in twenty-six NDAs. It is available from forty-three suppliers. Additional details are available on the MELOXICAM profile page.

The generic ingredient in MELOXICAM is meloxicam. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for 021530

Tradename:	MELOXICAM
Applicant:	Avondale Pharms
Ingredient:	meloxicam
Patents:	0

Pharmacology for NDA: 021530

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 021530

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	SUSPENSION;ORAL	021530	NDA	Avondale Pharmaceuticals, LLC	71740-339	71740-339-11	1 BOTTLE, PLASTIC in 1 CARTON (71740-339-11) / 100 mL in 1 BOTTLE, PLASTIC
MELOXICAM	meloxicam	SUSPENSION;ORAL	021530	NDA	Redmont Pharmaceuticals, LLC	71741-228	71741-228-10	1 BOTTLE, PLASTIC in 1 CARTON (71741-228-10) / 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jun 1, 2004	TE:		RLD:	Yes

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