Oxaprozin
OXAPROZIN
Approved
Approval ID
e77d2b9e-84df-4733-b654-16e93618efce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-100
Application NumberANDA075849
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIM
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT