Details for New Drug Application (NDA): 211398

NDA 211398 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-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 211398

Tradename:	MELOXICAM
Applicant:	Novitium Pharma
Ingredient:	meloxicam
Patents:	0

Pharmacology for NDA: 211398

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 211398

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELOXICAM	meloxicam	CAPSULE;ORAL	211398	ANDA	ANI Pharmaceuticals, Inc.	70954-076	70954-076-10	30 CAPSULE in 1 BOTTLE (70954-076-10)
MELOXICAM	meloxicam	CAPSULE;ORAL	211398	ANDA	ANI Pharmaceuticals, Inc.	70954-076	70954-076-20	90 CAPSULE in 1 BOTTLE (70954-076-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Mar 9, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Mar 9, 2021	TE:	AB	RLD:	No

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