Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022496

Expand all

EXPAREL (BUPIVACAINE)
133MG/10ML (13.3MG/ML) Marketing Status: Prescription

Active Ingredient: BUPIVACAINE
Proprietary Name: EXPAREL
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 133MG/10ML (13.3MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022496
Product Number: 001
Approval Date: Oct 28, 2011
Applicant Holder Full Name: PACIRA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EXPAREL (BUPIVACAINE)
266MG/20ML (13.3MG/ML) Marketing Status: Prescription

Active Ingredient: BUPIVACAINE
Proprietary Name: EXPAREL
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 266MG/20ML (13.3MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022496
Product Number: 002
Approval Date: Oct 28, 2011
Applicant Holder Full Name: PACIRA PHARMACEUTICALS INC
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