IMPAVIDO
These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
bcb387ac-2e90-4f5e-94b2-d3635190678e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Profounda, Inc.
DUNS: 078862060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
miltefosine
PRODUCT DETAILS
NDC Product Code69051-300
Application NumberNDA204684
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 11, 2023
Generic Namemiltefosine
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MILTEFOSINEActive
Quantity: 50 mg in 1 1
Code: 53EY29W7EC
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT