Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216620
Company: ANNORA PHARMA

Products on ANDA 216620

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No
ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216620Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 216620

ELTROMBOPAG OLAMINE

FOR SUSPENSION;ORAL; EQ 12.5MG ACID/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	216620	ANNORA PHARMA
PROMACTA KIT	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	207027	NOVARTIS

FOR SUSPENSION;ORAL; EQ 25MG ACID/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	216620	ANNORA PHARMA
PROMACTA KIT	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	207027	NOVARTIS