Astelin
ASTELIN (azelastine hydrochloride) Nasal Spray, 137 mcg IN-023S6-07 Rev. 1/09 For Intranasal Use Only
Approved
Approval ID
944349ca-7cdb-441a-8fd0-b8616857d338
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azelastine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5072
Application NumberNDA020114
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azelastine Hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateNovember 29, 2010
FDA Product Classification
INGREDIENTS (2)
BENZALKONIUM CHLORIDEInactive
Quantity: 125 ug in 1 1
Code: F5UM2KM3W7
Classification: IACT
AZELASTINE HYDROCHLORIDEActive
Quantity: 137 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB