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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 208633

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NDA 208633 describes OXAPROZIN, which is a drug marketed by Actavis Elizabeth, Amneal Pharms Co, Chartwell, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Pangea, Pharmobedient, Regcon Holdings, 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 are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.

Summary for 208633

Tradename:	OXAPROZIN
Applicant:	Amneal Pharms Co
Ingredient:	oxaprozin
Patents:	0

Pharmacology for NDA: 208633

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 208633

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Amneal Pharmaceuticals NY LLC	69238-1120	69238-1120-1	100 TABLET in 1 BOTTLE (69238-1120-1)
OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Amneal Pharmaceuticals NY LLC	69238-1120	69238-1120-5	500 TABLET in 1 BOTTLE (69238-1120-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	May 4, 2017	TE:	AB	RLD:	No

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