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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69051-300
Application NumberNDA204684
Product Classification
M
Marketing Category
C73594
G
Generic Name
miltefosine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
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