Last Updated: August 11, 2026

Details for New Drug Application (NDA): 208815

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NDA 208815 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, and Zydus Pharms, and is included in ten NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Summary for 208815

Tradename:	ELTROMBOPAG OLAMINE
Applicant:	Actavis Labs Fl
Ingredient:	eltrombopag olamine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG ACID
Approval Date:	Jun 17, 2026	TE:	AB	RLD:	No

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