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Generated: May 27, 2017

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Details for New Drug Application (NDA): 204684

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NDA 204684 describes IMPAVIDO, which is a drug marketed by Knight Theraps and is included in one NDA. It is available from two suppliers. Additional details are available on the IMPAVIDO profile page.

The generic ingredient in IMPAVIDO is miltefosine. Two suppliers are listed for this compound. Additional details are available on the miltefosine profile page.

Summary for NDA: 204684

Formulation / Manufacturing:see details

Pharmacology for NDA: 204684

Suppliers and Packaging for NDA: 204684

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 204684 NDA Paladin Therapeutics Inc. 61744-050 61744-050-01 2 BLISTER PACK in 1 CARTON (61744-050-01) > 14 CAPSULE in 1 BLISTER PACK
CAPSULE;ORAL 204684 NDA Profounda, Inc. 69051-300 69051-300-01 2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 19, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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