Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfatesand Dexamethasone OphthalmicSuspensionSterile
Approved
Approval ID
8060a686-f1e1-4171-9b99-28791e502bdb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2010
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.
neomycin sulfate, polymyxin B sulfate and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-595
Application NumberANDA062721
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate, polymyxin B sulfate and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 24, 2006
FDA Product Classification
INGREDIENTS (9)
waterInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
neomycin sulfateActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
polymyxin B sulfateActive
Quantity: 10000 mg in 1 mL
Code: 19371312D4
Classification: ACTIB
dexamethasoneActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT