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FDA Approval

SYMFI LO

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Mylan Specialty L.P.
DUNS: 194775557
Effective Date
October 15, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Efavirenz(400 mg in 1 1)
Lamivudine(300 mg in 1 1)
Tenofovir disoproxil(300 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SYMFI LO

Product Details

NDC Product Code
49502-425
Application Number
NDA208255
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 9, 2019
EfavirenzActive
Code: JE6H2O27P8Class: ACTIBQuantity: 400 mg in 1 1
Code: 2T8Q726O95Class: ACTIBQuantity: 300 mg in 1 1
Code: OTT9J7900IClass: ACTIBQuantity: 300 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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