Details for New Drug Application (NDA): 077920

NDA 077920 describes MELOXICAM, which is a drug marketed by Lupin Ltd, Novitium Pharma, Avondale Pharms, Aiping Pharm Inc, Anda Repository, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cipla, Corepharma, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Impax Labs Inc, Lupin Pharms, Mylan, Natco Pharma, Puracap Pharm, Roxane, 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-six 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-six suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for 077920

Tradename:	MELOXICAM
Applicant:	Aiping Pharm Inc
Ingredient:	meloxicam
Patents:	0

Pharmacology for NDA: 077920

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 077920

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	TABLET;ORAL	077920	ANDA	AiPing Pharmaceutical, Inc	11788-098	11788-098-00	83000 TABLET in 1 CARTON (11788-098-00)
MELOXICAM	meloxicam	TABLET;ORAL	077920	ANDA	AiPing Pharmaceutical, Inc	11788-099	11788-099-00	83000 TABLET in 1 CARTON (11788-099-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Jul 19, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jul 19, 2006	TE:	AB	RLD:	No

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