Product Details for NDA 022569
LAZANDA (FENTANYL CITRATE)
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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)
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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)
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
Proprietary Name: LAZANDA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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