NDC Code: |
16590-169 |
Proprietary Name: |
NEOMYCIN and POLYMYXIN B SULFATES and HYDROCORTISONE |
Suffix: |
|
Non-Proprietary Name: |
NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE |
Dosage Form: |
SOLUTION/ DROPS |
Method: |
AURICULAR (OTIC) |
Original Marketing Date: |
29-12-1995 |
Category Name: |
ANDA |
Application Number: |
ANDA064053 |
Labeler: |
STAT RX USA LLC |
Substance Name: |
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
Active Numerator Strength: |
10; 3.5; 10000 |
Active Ingredient Unit: |
mg/mL; mg/mL; [USP'U]/mL |
Pharm Classes: |
Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
DEA Schedule: |
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