Details for New Drug Application (NDA): 020630

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NDA 020630 describes ULTIVA, which is a drug marketed by Mylan Institutional and is included in one NDA. It is available from one supplier. Additional details are available on the ULTIVA profile page.

The generic ingredient in ULTIVA is remifentanil hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.

Summary for 020630

Tradename:	ULTIVA
Applicant:	Mylan Institutional
Ingredient:	remifentanil hydrochloride
Patents:	0

Pharmacology for NDA: 020630

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 020630

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630	NDA	Mylan Institutional LLC	67457-912	67457-912-01	10 VIAL, GLASS in 1 CARTON (67457-912-01) / 3 mL in 1 VIAL, GLASS (67457-912-00)
ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630	NDA	Mylan Institutional LLC	67457-913	67457-913-02	10 VIAL, GLASS in 1 CARTON (67457-913-02) / 5 mL in 1 VIAL, GLASS (67457-913-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/VIAL
Approval Date:	Jul 12, 1996	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/VIAL
Approval Date:	Jul 12, 1996	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/VIAL
Approval Date:	Jul 12, 1996	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020630

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	⤷ Subscribe	⤷ Subscribe
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	⤷ Subscribe	⤷ Subscribe
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	⤷ Subscribe	⤷ Subscribe
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	⤷ Subscribe	⤷ Subscribe
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