SYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated 
Mylan Laboratories Limited

----------

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

SYMFI LO (efavirenz, lamivudine, and tenofovir disoproxil fumarate) Tablets 400 mg/300 mg/300 mg Carton Label
SYMFI LO 
efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-278
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8) EFAVIRENZ400 mg
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95) LAMIVUDINE300 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE300 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize21mm
FlavorImprint Code M;TLE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65015-278-141 in 1 CARTON02/23/2018
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20825502/23/2018
Labeler - Mylan Laboratories Limited (650547156)

Revised: 2/2018
Document Id: 82a033fa-ef47-415e-a1df-4edc1ff40dc4
Set id: 82a033fa-ef47-415e-a1df-4edc1ff40dc4
Version: 1
Effective Time: 20180219
 
Mylan Laboratories Limited