U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022569

Expand all

LAZANDA (FENTANYL CITRATE)
EQ 0.1MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022569
Product Number: 001
Approval Date: Jun 30, 2011
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LAZANDA (FENTANYL CITRATE)
EQ 0.3MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022569
Product Number: 003
Approval Date: Dec 21, 2015
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LAZANDA (FENTANYL CITRATE)
EQ 0.4MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022569
Product Number: 002
Approval Date: Jun 30, 2011
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top