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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. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ULTIVA profile page.

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

Summary for NDA: 020630

Tradename:
ULTIVA
Applicant:
Mylan Institutional
Ingredient:
remifentanil hydrochloride
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020630

Mechanism of ActionFull 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 67457-198 67457-198-03 10 VIAL, GLASS in 1 CARTON (67457-198-03) > 3 mL in 1 VIAL, GLASS (67457-198-00)
ULTIVA
remifentanil hydrochloride
INJECTABLE;INJECTION 020630 NDA Mylan Institutional LLC 67457-198 67457-198-05 10 VIAL, GLASS in 1 CARTON (67457-198-05) > 5 mL in 1 VIAL, GLASS (67457-198-99)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/VIAL
Approval Date:Jul 12, 1996TE:RLD:No
Patent:5,866,591*PEDPatent Expiration:Mar 10, 2018Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/VIAL
Approval Date:Jul 12, 1996TE:RLD:No
Patent:5,866,591*PEDPatent Expiration:Mar 10, 2018Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/VIAL
Approval Date:Jul 12, 1996TE:RLD:Yes
Patent:5,866,591*PEDPatent Expiration:Mar 10, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020630

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional
ULTIVA
remifentanil hydrochloride
INJECTABLE;INJECTION020630-001Jul 12, 19965,019,583*PED► subscribe
Mylan Institutional
ULTIVA
remifentanil hydrochloride
INJECTABLE;INJECTION020630-003Jul 12, 19965,019,583*PED► subscribe
Mylan Institutional
ULTIVA
remifentanil hydrochloride
INJECTABLE;INJECTION020630-002Jul 12, 19965,466,700*PED► subscribe
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