Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ODEFSEY
Product Details
NDC Product Code
50090-2340Application Number
NDA208351Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 28, 2017CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
EmtricitabineActive
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
TenofovirActive
Code: FWF6Q91TZOClass: ACTIRQuantity: 25 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
RilpivirineActive
Code: 212WAX8KDDClass: ACTIMQuantity: 25 mg in 1 1
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT