Details for New Drug Application (NDA): 220033

NDA 220033 describes ELTROMBOPAG OLAMINE, which is a drug marketed by Annora Pharma, Amneal, Dr Reddys, Hetero Labs Ltd V, MSN, Somerset Theraps Llc, Zenara, and Zydus Pharms, and is included in eight NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Summary for 220033

Tradename:	ELTROMBOPAG OLAMINE
Applicant:	Zenara
Ingredient:	eltrombopag olamine
Patents:	0

Suppliers and Packaging for NDA: 220033

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	220033	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0962	0054-0962-13	30 TABLET in 1 BOTTLE (0054-0962-13)
ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	220033	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0963	0054-0963-13	30 TABLET in 1 BOTTLE (0054-0963-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG ACID
Approval Date:	Apr 8, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG ACID
Approval Date:	Apr 8, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG ACID
Approval Date:	Apr 8, 2026	TE:	AB	RLD:	No

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