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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

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