Pretomanid
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2019LIMITED POPULATION
Approved
Approval ID
f1906fc9-cb3c-4e13-8a4a-da76100c1bf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2022
Manufacturers
FDA
Viatris Specialty LLC
DUNS: 117455616
FDA
Mylan Specialty L.P.
DUNS: 194775557
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pretomanid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-476
Application NumberNDA212862
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pretomanid
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2020
FDA Product Classification
INGREDIENTS (15)
PretomanidActive
Quantity: 200 mg in 1 1
Code: 2XOI31YC4N
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT