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Generated: September 22, 2017

DrugPatentWatch Database Preview

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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
IMPAVIDO
miltefosine
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
IMPAVIDO
miltefosine
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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Serving 500+ biopharmaceutical companies globally:

Teva
McKinsey
Fuji
Queensland Health
Cerilliant
Colorcon
Cantor Fitzgerald
Merck
Chubb
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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