← FDA DRUG APPROVALS

FDA NDA · NDA050023

NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE

Sponsor: HARROW EYE

APPLICATION
NDA050023
TYPE
NDA
ORIGINAL APPROVAL
1963-06-06
LATEST ACTION
2021-05-14
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

MAXITROL · ReferencePrescription
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2021-05-14Labeling · Supplement 37 · standard — Letter ↗AP
2017-12-18Labeling · Supplement 36 · standard — Label ↗AP
2017-04-10Labeling · Supplement 32 · standard — Label ↗AP
2015-05-27Manufacturing (CMC) · Supplement 31AP
2008-04-24Labeling · Supplement 25 · standard — Label ↗AP
2002-12-11Manufacturing (CMC) · Supplement 23AP
2002-12-04Manufacturing (CMC) · Supplement 22AP
2000-10-10Manufacturing (CMC) · Supplement 21AP
2000-02-25Manufacturing (CMC) · Supplement 20AP
1999-08-17Manufacturing (CMC) · Supplement 19AP
1999-03-11Manufacturing (CMC) · Supplement 17AP
1999-02-05Manufacturing (CMC) · Supplement 18AP
1998-08-04Manufacturing (CMC) · Supplement 16AP
1996-03-18Manufacturing (CMC) · Supplement 14AP
1995-11-01Manufacturing (CMC) · Supplement 12AP
1995-11-01Manufacturing (CMC) · Supplement 13AP
1995-08-30Labeling · Supplement 11 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 8AP
1994-07-27Manufacturing (CMC) · Supplement 10AP
1993-01-22Manufacturing (CMC) · Supplement 9AP
1989-03-03Manufacturing (CMC) · Supplement 6AP
1977-03-25Manufacturing (CMC) · Supplement 5AP
1976-03-01Manufacturing (CMC) · Supplement 4AP
1973-02-20Manufacturing (CMC) · Supplement 3AP
1971-10-14Manufacturing (CMC) · Supplement 2AP
1966-12-14Manufacturing (CMC) · Supplement 1AP
1963-06-06UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →