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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075987

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NDA 075987 describes OXAPROZIN, which is a drug marketed by Aarxion Anda Hlding, Actavis Elizabeth, Amneal Pharms Co, Chartwell, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Pangea, Pharmobedient, Sandoz, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the OXAPROZIN profile page.

The generic ingredient in OXAPROZIN is oxaprozin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.

Summary for 075987

Tradename:	OXAPROZIN
Applicant:	Chartwell
Ingredient:	oxaprozin
Patents:	0

Pharmacology for NDA: 075987

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 075987

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAPROZIN	oxaprozin	TABLET;ORAL	075987	ANDA	Chartwell RX, LLC.	62135-176	62135-176-18	180 TABLET in 1 BOTTLE (62135-176-18)
OXAPROZIN	oxaprozin	TABLET;ORAL	075987	ANDA	Chartwell RX, LLC.	62135-176	62135-176-60	60 TABLET in 1 BOTTLE (62135-176-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Sep 2, 2004	TE:	AB	RLD:	No

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