Details for New Drug Application (NDA): 077882

NDA 077882 describes MELOXICAM, which is a drug marketed by Lupin, 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-five 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-seven suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for 077882

Tradename:	MELOXICAM
Applicant:	Corepharma
Ingredient:	meloxicam
Patents:	0

Pharmacology for NDA: 077882

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 077882

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	TABLET;ORAL	077882	ANDA	Terrain Pharmaceuticals, Inc.	53225-3015	53225-3015-1	30 TABLET in 1 BOTTLE (53225-3015-1)
MELOXICAM	meloxicam	TABLET;ORAL	077882	ANDA	Terrain Pharmaceuticals, Inc.	53225-3015	53225-3015-2	60 TABLET in 1 BOTTLE (53225-3015-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Jul 20, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jul 20, 2006	TE:	AB	RLD:	No

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