ETODOLAC
ETODOLAC TABLETS 400 MG
Approved
Approval ID
b17228a1-38c3-4fa3-a83d-0654f18edabc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ETODOLAC
PRODUCT DETAILS
NDC Product Code42549-511
Application NumberANDA076004
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 3, 2012
Generic NameETODOLAC
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ETODOLACActive
Quantity: 400 mg in 1 1
Code: 2M36281008
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT