Details for New Drug Application (NDA): 077927

NDA 077927 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-two 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-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for 077927

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

Pharmacology for NDA: 077927

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 077927

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	TABLET;ORAL	077927	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-124	29300-124-01	100 TABLET in 1 BOTTLE (29300-124-01)
MELOXICAM	meloxicam	TABLET;ORAL	077927	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-124	29300-124-05	500 TABLET in 1 BOTTLE (29300-124-05)

Profile for product number 001

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

Profile for product number 002

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

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