Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
70518-2198
11-digit product format
705182198
Labeler code
70518
Product ID
70518-2198_97377ec6-e78c-71c0-e053-2a95a90a3dbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA062341
Marketing category
ANDA
Marketing start
2019-07-10
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record