Kovanaze
These highlights do not include all the information needed to use KOVANAZE NASAL SPRAY safely and effectively. See full prescribing information for KOVANAZE NASAL SPRAY. KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial U.S. Approval: 2016
Approved
Approval ID
d2af5404-3cfe-445d-8328-19e667ecdc43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2018
Manufacturers
FDA
St. Renatus
DUNS: 825145191
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tetracaine hydrochloride and oxymetazoline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69803-100
Application NumberNDA208032
Product Classification
M
Marketing Category
C73594
G
Generic Name
tetracaine hydrochloride and oxymetazoline hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateNovember 16, 2018
FDA Product Classification
INGREDIENTS (9)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TETRACAINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 mL
Code: 5NF5D4OPCI
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
OXYMETAZOLINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: K89MJ0S5VY
Classification: ACTIB
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 11/14/2018
RECENT MAJOR CHANGES
Warnings and Precautions, Methemoglobinemia ( 5.1) 11/2018