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Details for New Drug Application (NDA): 022291

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NDA 022291 describes PROMACTA, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There are twenty-two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PROMACTA profile page.

The generic ingredient in PROMACTA is eltrombopag olamine. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Suppliers and Packaging for NDA: 022291

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
eltrombopag olamine
TABLET;ORAL 022291 NDA GlaxoSmithKline LLC 0007-4640 0007-4640-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4640-13)
eltrombopag olamine
TABLET;ORAL 022291 NDA GlaxoSmithKline LLC 0007-4641 0007-4641-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4641-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG ACID
Approval Date:Nov 20, 2008TE:RLD:No
Patent:6,280,959*PEDPatent Expiration:Apr 30, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:7,160,870*PEDPatent Expiration:May 20, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:7,332,481*PEDPatent Expiration:Nov 24, 2021Product Flag?Substance Flag?Delist Request?Y

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