Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020630

Expand all

ULTIVA (REMIFENTANIL HYDROCHLORIDE)
EQ 1MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: ULTIVA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020630
Product Number: 001
Approval Date: Jul 12, 1996
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ULTIVA (REMIFENTANIL HYDROCHLORIDE)
EQ 2MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: ULTIVA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020630
Product Number: 002
Approval Date: Jul 12, 1996
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ULTIVA (REMIFENTANIL HYDROCHLORIDE)
EQ 5MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: REMIFENTANIL HYDROCHLORIDE
Proprietary Name: ULTIVA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020630
Product Number: 003
Approval Date: Jul 12, 1996
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English