LOFENA
LOFENA™ (diclofenac potassium tablets, USP)
Approved
Approval ID
49bd64cc-5edb-44f2-8e24-1249f6a76663
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
CARWIN PHARMACEUTICAL ASSOCIATES, LLC
DUNS: 079217215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DICLOFENAC POTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-180
Application NumberANDA076561
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICLOFENAC POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DICLOFENAC POTASSIUMActive
Quantity: 25 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT