Oxaprozin
REPACKAGED OXAPROZIN TABLETS These highlights do not include all the information needed to use OXAPROZIN TABLETS safely and effectively See full prescribing information for OXAPROZIN TABLETS Initial U.S. Approval 1992.
Approved
Approval ID
61cf2924-8dc0-7f5c-e053-2991aa0ac527
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2018
Manufacturers
FDA
California Pharmaceutical LLC
DUNS: 021420944
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 Code70332-311
Application NumberANDA208633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2018
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB