← FDA DRUG APPROVALS
FDA ANDA · ANDA217803
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
neomycin sulfate, polymyxin b sulfate, hydrocortisone
Sponsor: AMNEAL
APPLICATION
ANDA217803
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-29
LATEST ACTION
2025-10-29
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEPrescription
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OTIC
Approval history
2025-10-29UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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