Drugs@FDA: FDA Approved Drug Products

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

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
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
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
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020630 MYLAN INSTITUTIONAL

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