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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020630
Company: MYLAN INSTITUTIONAL

Products on NDA 020630

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020630

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
12/15/2023	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020630s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020630Orig1s030ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 020630

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020630s030lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
06/21/2018	SUPPL-18	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 020630

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	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

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