LAZANDA
Lazanda (fentanyl citrate) Nasal Spray, 100 mcg, 300 mcg, 400 mcg
Approved
Approval ID
73f38bde-2132-2b5a-e053-2a91aa0a6efb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2021
Manufacturers
FDA
West Therapeutic Development LLC
DUNS: 080707245
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71500-130
Application NumberNDA022569
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FENTANYL CITRATEActive
Quantity: 300 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
PECTINInactive
Code: 89NA02M4RX
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71500-110
Application NumberNDA022569
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PECTINInactive
Code: 89NA02M4RX
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FENTANYL CITRATEActive
Quantity: 100 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71500-140
Application NumberNDA022569
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (11)
FENTANYL CITRATEActive
Quantity: 400 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PECTINInactive
Code: 89NA02M4RX
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT