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Generated: November 20, 2018

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Details for New Drug Application (NDA): 207027

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NDA 207027 describes PROMACTA KIT, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are eight 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. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 207027
Tradename:PROMACTA KIT
Applicant:Novartis Pharms Corp
Ingredient:eltrombopag olamine
Patents:8
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 0078-0972 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:Jun 11, 2018
Regulatory Exclusivity Use:DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP
Regulatory Exclusivity Expiration:Jun 11, 2018
Regulatory Exclusivity Use:INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.
Regulatory Exclusivity Expiration:Dec 11, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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McKesson
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Colorcon
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Medtronic

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