Oxaprozin
These highlights do not include all the information needed to use OXAPROZIN TABLETS safely and effectively. See full prescribing information for OXAPROZIN TABLETS. OXAPROZIN tablets, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
e2178942-ac37-4a88-83a9-221356b9a504
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2021
Manufacturers
FDA
Eon Labs, Inc.
DUNS: 012656273
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxaprozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0185-0141
Application NumberANDA075845
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2021
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (100 MPA.S)Inactive
Code: 4GFU244C4J
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT