Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208554
Company: BAXTER HLTHCARE CORP

Products on ANDA 208554

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPTIFIBATIDE	EPTIFIBATIDE	2MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208554

EPTIFIBATIDE

INJECTABLE;INJECTION; 75MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	208554	BAXTER HLTHCARE CORP
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206127	EUGIA PHARMA
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	213599	MEITHEAL
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	203258	MYLAN LABS LTD
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	204693	SAGENT PHARMS INC
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	213081	SHUANGCHENG
EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209864	SLATE RUN PHARMA