Natroba
These highlights do not include all the information needed to use NATROBA Topical Suspension safely and effectively. See full prescribing information for NATROBA Topical Suspension. NATROBA (spinosad) topical suspension Initial U.S. Approval: 2011
Approved
Approval ID
fa90ccc8-2df0-49f7-8878-2b33e34cd272
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2021
Manufacturers
FDA
ParaPRO LLC
DUNS: 186639006
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
spinosad
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52246-929
Application NumberNDA022408
Product Classification
M
Marketing Category
C73594
G
Generic Name
spinosad
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (13)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SPINOSADActive
Quantity: 9 mg in 1 mL
Code: XPA88EAP6V
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
STEARALKONIUM CHLORIDEInactive
Code: 0OUO26BB88
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT