PROMACTA

Product NDC

0007-4643

11-digit product format

000074643

Labeler code

0007

Product ID

0007-4643_c7c46a73-1f77-45f6-ab60-1aa8f9e87463

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

eltrombopag olamine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

GlaxoSmithKline LLC

Application

NDA022291

Marketing category

NDA

Marketing start

2012-01-02

Marketing end

2019-04-30

Substance

ELTROMBOPAG OLAMINE

Active strength

13 mg/1

Pharmacologic classes

Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record