Details for New Drug Application (NDA): 077921

NDA 077921 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, Esjay Pharma, Glenmark Pharms Ltd, Impax Labs Inc, Lupin Pharms, Mylan, Natco Pharma, Puracap Pharm, Roxane, 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-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-two suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for 077921

Tradename:	MELOXICAM
Applicant:	Zydus Pharms Usa
Ingredient:	meloxicam
Patents:	0

Pharmacology for NDA: 077921

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 077921

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	TABLET;ORAL	077921	ANDA	A-S Medication Solutions	50090-5339	50090-5339-0	7 TABLET in 1 BOTTLE (50090-5339-0)
MELOXICAM	meloxicam	TABLET;ORAL	077921	ANDA	A-S Medication Solutions	50090-5339	50090-5339-1	14 TABLET in 1 BOTTLE (50090-5339-1)

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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