DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204684
, 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
||National Drug Code
||Paladin Therapeutics Inc.
||2 BLISTER PACK in 1 CARTON (61744-050-01) > 14 CAPSULE in 1 BLISTER PACK
||2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK
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Summary for product number 001
|Approval Date:||Mar 19, 2014||TE:||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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