Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075846

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NDA 075846 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 seven suppliers. Additional details are available on the OXAPROZIN profile page.

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

Summary for 075846

Tradename:	OXAPROZIN
Applicant:	Ivax Sub Teva Pharms
Ingredient:	oxaprozin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	May 13, 2002	TE:		RLD:	No

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