Details for New Drug Application (NDA): 078008

NDA 078008 describes MELOXICAM, which is a drug marketed by Lupin Ltd, Novitium Pharma, Avondale Pharms, Anda Repository, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cipla, Corepharma, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Impax Labs Inc, Lupin Pharms, Mylan, Puracap Pharm, Roxane, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Taro, Unichem, Yabao Pharm, Yung Shin Pharm, and Zydus Pharms Usa, and is included in twenty-six NDAs. It is available from forty-seven 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 078008

Tradename:	MELOXICAM
Applicant:	Aurobindo Pharma
Ingredient:	meloxicam
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 078008

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 078008

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	TABLET;ORAL	078008	ANDA	Rising Pharma Holdings, Inc.	16571-776	16571-776-01	100 TABLET in 1 BOTTLE (16571-776-01)
MELOXICAM	meloxicam	TABLET;ORAL	078008	ANDA	Rising Pharma Holdings, Inc.	16571-776	16571-776-10	1000 TABLET in 1 BOTTLE (16571-776-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Oct 2, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Oct 2, 2006	TE:	AB	RLD:	No

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