AK-Con
ALBALON (naphazoline hydrochloride ophthalmic solution, USP) 0.1%
Approved
Approval ID
297f0888-729c-4ce6-8779-6b239abf3c93
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2011
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
naphazoline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-915
Application NumberANDA083590
Product Classification
M
Marketing Category
C73584
G
Generic Name
naphazoline hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 30, 2006
FDA Product Classification
INGREDIENTS (8)
waterInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
naphazoline hydrochlorideActive
Quantity: 1 mg in 1 mL
Code: MZ1131787D
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT