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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021530

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NDA 021530 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 021530

Tradename:	MELOXICAM
Applicant:	Avondale Pharms
Ingredient:	meloxicam
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021530

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 021530

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	SUSPENSION;ORAL	021530	NDA	Avondale Pharmaceuticals, LLC	71740-339	71740-339-11	1 BOTTLE, PLASTIC in 1 CARTON (71740-339-11) / 100 mL in 1 BOTTLE, PLASTIC
MELOXICAM	meloxicam	SUSPENSION;ORAL	021530	NDA AUTHORIZED GENERIC	Emerald Therapeutics, LLC	72919-124	72919-124-10	1 BOTTLE, PLASTIC in 1 CARTON (72919-124-10) / 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 1, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021530

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avondale Pharms	MELOXICAM	meloxicam	SUSPENSION;ORAL	021530-001	Jun 1, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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