Oxaprozin
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . , for oral use Initial U.S. Approval: 1992
Approved
Approval ID
90b7b3db-0cf4-ef30-e053-2995a90ac69c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2019
Manufacturers
FDA
St Mary's Medical Park Pharmacy
DUNS: 063050751
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 Code60760-092
Application NumberANDA208633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2019
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB