← FDA DRUG APPROVALS
FDA ANDA · ANDA064065
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Sponsor: BAUSCH AND LOMB INC
APPLICATION
ANDA064065
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-28
LATEST ACTION
2025-07-01
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
OTICAIRPrescription
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OTIC
Approval history
2025-07-01Labeling · Supplement 61 · standardAP
2025-07-01Labeling · Supplement 52 · standardAP
2003-04-18Labeling · Supplement 24AP
2002-06-12Manufacturing (CMC) · Supplement 21AP
2002-04-17Manufacturing (CMC) · Supplement 22AP
2002-02-05Manufacturing (CMC) · Supplement 20AP
2001-11-27Manufacturing (CMC) · Supplement 19AP
2001-03-07Manufacturing (CMC) · Supplement 18AP
2001-02-02Manufacturing (CMC) · Supplement 17AP
2000-09-15Manufacturing (CMC) · Supplement 16AP
2000-08-21Manufacturing (CMC) · Supplement 14AP
2000-06-27Manufacturing (CMC) · Supplement 15AP
2000-04-28Manufacturing (CMC) · Supplement 10AP
2000-04-28Manufacturing (CMC) · Supplement 13AP
1999-06-07Manufacturing (CMC) · Supplement 12AP
1999-03-05Manufacturing (CMC) · Supplement 11AP
1998-11-19Manufacturing (CMC) · Supplement 9AP
1998-06-15Manufacturing (CMC) · Supplement 8AP
1998-05-19Manufacturing (CMC) · Supplement 6AP
1998-05-04Manufacturing (CMC) · Supplement 7AP
1997-11-12Manufacturing (CMC) · Supplement 5AP
1997-09-18Manufacturing (CMC) · Supplement 4AP
1997-09-03Manufacturing (CMC) · Supplement 2AP
1997-04-29Manufacturing (CMC) · Supplement 1AP
1996-08-28OriginalAP
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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