APPLICATION
NDA050544
TYPE
NDA
ORIGINAL APPROVAL
1983-02-28
LATEST ACTION
1998-01-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NETROMYCINDiscontinued
NETILMICIN SULFATE EQ 25MG BASE/ML · INJECTABLE · INJECTION
NETROMYCINDiscontinued
NETILMICIN SULFATE EQ 100MG BASE/ML · INJECTABLE · INJECTION
NETROMYCINDiscontinued
NETILMICIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
1998-01-13Manufacturing (CMC) · Supplement 16 · standardAP
1997-11-17Manufacturing (CMC) · Supplement 15 · standardAP
1997-07-01Manufacturing (CMC) · Supplement 14 · standardAP
1996-11-20Manufacturing (CMC) · Supplement 13 · standardAP
1994-02-22Manufacturing (CMC) · Supplement 12 · standardAP
1989-02-14Manufacturing (CMC) · Supplement 11 · standardAP
1987-05-15Labeling · Supplement 10 · standardAP
1986-03-12Manufacturing (CMC) · Supplement 9 · standardAP
1984-06-12Manufacturing (CMC) · Supplement 8 · standardAP
1984-05-11Manufacturing (CMC) · Supplement 6 · standardAP
1984-02-18Labeling · Supplement 4 · standardAP
1983-05-17Manufacturing (CMC) · Supplement 5 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 1 · standardAP
1983-02-28Type 1 - New Molecular Entity · 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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