Details for New Drug Application (NDA): 020630
✉ Email this page to a colleague
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. Three suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.
The generic ingredient in ULTIVA is remifentanil hydrochloride. There are four drug master file entries for this compound. Three 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 |
| Formulation / Manufacturing: | see details |
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 | 67457-198 | 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) |
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
Complete Access Available with Subscription
