Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020630
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/12/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020630Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020630s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020630Orig1s020ltr.pdf
06/21/2018 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020630Orig1s016ltr.pdf
01/12/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/11/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/03/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/20/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/19/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/19/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2004 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-005_ultiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20630se5-005ltr.pdf
06/23/1999 SUPPL-3 Labeling

Label is not available on this site.

11/23/1999 SUPPL-2 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

10/15/1999 SUPPL-1 Efficacy-New Patient Population

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020630s020lbl.pdf
06/21/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
06/21/2018 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf
03/08/2004 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-005_ultiva_lbl.pdf

ULTIVA

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

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