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Drugs@FDA: FDA-Approved Drugs

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

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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