Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pretomanid
Product Details
NDC Product Code
49502-476Application Number
NDA212862Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 15, 2020PretomanidActive
Code: 2XOI31YC4NClass: ACTIBQuantity: 200 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT