APPLICATION
ANDA062822
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-29
LATEST ACTION
2000-08-10
ROUTE
OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
PEDIOTICDiscontinued
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OTIC
Approval history
2000-08-10Labeling · Supplement 8AP
1999-08-03Labeling · Supplement 2AP
1999-07-23Manufacturing (CMC) · Supplement 7AP
1995-02-14Manufacturing (CMC) · Supplement 6AP
1994-02-17Labeling · Supplement 4AP
1993-09-08Labeling · Supplement 3AP
1987-09-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.