Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206223
Company: FRESENIUS KABI USA

Products on ANDA 206223

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206223Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/15/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206223

REMIFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 1MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206223	FRESENIUS KABI USA
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210594	HIKMA
ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020630	MYLAN INSTITUTIONAL

INJECTABLE;INJECTION; EQ 2MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206223	FRESENIUS KABI USA
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210594	HIKMA
ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020630	MYLAN INSTITUTIONAL

INJECTABLE;INJECTION; EQ 5MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206223	FRESENIUS KABI USA
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210594	HIKMA
ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020630	MYLAN INSTITUTIONAL