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Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207027


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NDA 207027 describes PROMACTA KIT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the PROMACTA KIT profile page.

The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 207027
Tradename:PROMACTA KIT
Applicant:Novartis
Ingredient:eltrombopag olamine
Patents:7
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027 NDA Novartis Pharmaceuticals Corporation 0078-0697 0078-0697-61 1 CARTON in 1 KIT (0078-0697-61) > 30 PACKET in 1 CARTON (0078-0697-23) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19)
PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027 NDA Novartis Pharmaceuticals Corporation 0078-0972 0078-0972-61 1 CARTON in 1 KIT (0078-0972-61) > 30 PACKET in 1 CARTON (0078-0972-23) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 25MG ACID/PACKET
Approval Date:Aug 24, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 26, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Aug 26, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
Patent:  Start TrialPatent Expiration:May 20, 2023Product Flag?Substance Flag?Delist Request?Y

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