APPLICATION
NDA050344
TYPE
NDA
ORIGINAL APPROVAL
1974-03-12
LATEST ACTION
1999-09-28
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
STATROLDiscontinued
NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC
Approval history
1999-09-28Manufacturing (CMC) · Supplement 18 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 17 · standardAP
1997-09-09Labeling · Supplement 16 · standardAP
1996-11-29Manufacturing (CMC) · Supplement 15 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 14 · standardAP
1993-09-28Labeling · Supplement 13 · standardAP
1992-08-24Manufacturing (CMC) · Supplement 7 · standardAP
1992-02-03Manufacturing (CMC) · Supplement 2 · standardAP
1991-12-31Labeling · Supplement 1AP
1989-03-03Manufacturing (CMC) · Supplement 3 · standardAP
1988-03-22Manufacturing (CMC) · Supplement 6 · standardAP
1987-06-16Manufacturing (CMC) · Supplement 4 · standardAP
1984-08-08Labeling · Supplement 10AP
1983-11-23Labeling · Supplement 8AP
1983-11-23Manufacturing (CMC) · Supplement 9 · standardAP
1981-04-13Manufacturing (CMC) · Supplement 5 · standardAP
1974-03-12Type 5 - New Formulation or New Manufacturer · 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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