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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210594
Company: HIKMA

Products on ANDA 210594

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 210594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2020	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
06/18/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210594

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
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215635	NIVAGEN PHARMS INC
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
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215635	NIVAGEN PHARMS INC
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
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215635	NIVAGEN PHARMS INC
ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020630	MYLAN INSTITUTIONAL

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