Details for New Drug Application (NDA): 209938

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NDA 209938 describes ELTROMBOPAG OLAMINE, which is a drug marketed by Annora Pharma, Actavis Labs Fl, Amneal, Biocon Pharma, Dr Reddys, Hetero Labs Ltd V, Hikma, MSN, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the ELTROMBOPAG OLAMINE profile page.

The generic ingredient in ELTROMBOPAG OLAMINE is eltrombopag olamine. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	209938	ANDA	Teva Pharmaceuticals, Inc.	0480-4015	0480-4015-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-4015-56)
ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	209938	ANDA	Teva Pharmaceuticals, Inc.	0480-4031	0480-4031-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-4031-56)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG ACID
Approval Date:	Jul 13, 2026	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG ACID
Approval Date:	Jul 13, 2026	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 75MG ACID
Approval Date:	Jul 13, 2026	TE:	AB	RLD:	No

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