MedPath
FDA Approval

Biktarvy

October 31, 2023

HUMAN PRESCRIPTION DRUG LABEL

Tenofovir(25 mg in 1 1)
Emtricitabine(50 mg in 1 1)
Emtricitabine(200 mg in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

A-S Medication Solutions

830016429

Products (1)

Biktarvy

50090-6247

NDA210251

NDA (C73594)

ORAL

October 21, 2022

FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TenofovirActive
Code: FWF6Q91TZOClass: ACTIRQuantity: 25 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: 4L5MP1Y7W7Class: ACTIMQuantity: 50 mg in 1 1
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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