LAZANDA
These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda (Fentanyl) Nasal Spray CIIInitial U.S. Approval: 1968
Approved
Approval ID
39531d0c-db12-4627-81c9-6563076b637b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2012
Manufacturers
FDA
Archimedes Pharma US Inc.
DUNS: 962751306
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51772-311
Application NumberNDA022569
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (7)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
PectinInactive
Code: 89NA02M4RX
Classification: IACT
Fentanyl CitrateActive
Quantity: 100 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
Phenylethyl alcoholInactive
Code: ML9LGA7468
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Fentanyl Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51772-314
Application NumberNDA022569
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (7)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
PectinInactive
Code: 89NA02M4RX
Classification: IACT
Fentanyl CitrateActive
Quantity: 400 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
SucroseInactive
Code: C151H8M554
Classification: IACT
Phenylethyl alcoholInactive
Code: ML9LGA7468
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT