Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Renaissance Lakewood LLC
077744035
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Renaissance Lakewood LLC
West Therapeutic Development LLC
Renaissance Lakewood LLC
077744035
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LAZANDA
Product Details
NDC Product Code
71500-130Application Number
NDA022569Marketing Category
NDA (C73594)Route of Administration
NASALEffective Date
March 31, 2021CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 300 ug in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468Class: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
LAZANDA
Product Details
NDC Product Code
71500-110Application Number
NDA022569Marketing Category
NDA (C73594)Route of Administration
NASALEffective Date
March 31, 2021HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 100 ug in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LAZANDA
Product Details
NDC Product Code
71500-140Application Number
NDA022569Marketing Category
NDA (C73594)Route of Administration
NASALEffective Date
March 31, 2021FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 400 ug in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT