Details for New Drug Application (NDA): 219638

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NDA 219638 describes ELTROMBOPAG OLAMINE, which is a drug marketed by Annora Pharma, Amneal, Hetero Labs Ltd V, MSN, Somerset Theraps Llc, and Zydus Pharms, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the ELTROMBOPAG OLAMINE profile page.

The generic ingredient in ELTROMBOPAG OLAMINE is eltrombopag olamine. There are three drug master file entries for this compound. Nine 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	219638	ANDA	Somerset Therapeutics, LLC	70069-837	70069-837-01	30 TABLET, FILM COATED in 1 BOTTLE (70069-837-01)
ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	219638	ANDA	Somerset Therapeutics, LLC	70069-838	70069-838-01	30 TABLET, FILM COATED in 1 BOTTLE (70069-838-01)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG ACID
Approval Date:	Jan 14, 2026	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG ACID
Approval Date:	Jan 14, 2026	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG ACID
Approval Date:	Jan 14, 2026	TE:	AB	RLD:	No

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