OXAPROZIN
Oxaprozin 600 mg - 310
Approved
Approval ID
cb1c0ab4-a102-46fe-b4cf-0a43fd6d91d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2017
Manufacturers
FDA
California Pharmaceuticals 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 Code70332-310
Application NumberANDA075855
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXAPROZIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2017
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB