← FDA DRUG APPROVALS

FDA NDA · NDA050065

MAXITROL

neomycin sulfate, polymyxin b sulfate and dexamethasone

Sponsor: SANDOZ

APPLICATION
NDA050065
TYPE
NDA
ORIGINAL APPROVAL
1963-07-19
LATEST ACTION
2021-05-14
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

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

Approval history

2021-05-14Labeling · Supplement 65 · standard — Letter ↗AP
2017-12-18Labeling · Supplement 64 · standard — Label ↗AP
2017-04-12Labeling · Supplement 61 · standard — Label ↗AP
2015-10-06Manufacturing (CMC) · Supplement 60AP
2012-12-18Manufacturing (CMC) · Supplement 57AP
2012-12-10Manufacturing (CMC) · Supplement 58AP
2004-07-15Labeling · Supplement 43 · standard — Letter ↗AP
2004-07-15Manufacturing (CMC) · Supplement 44 — Label ↗AP
2003-07-23Labeling · Supplement 40 · standard — Letter ↗AP
2003-07-23Manufacturing (CMC) · Supplement 39 — Label ↗AP
2002-12-11Manufacturing (CMC) · Supplement 41AP
2001-02-09Manufacturing (CMC) · Supplement 38AP
1999-09-28Manufacturing (CMC) · Supplement 37AP
1999-04-07Manufacturing (CMC) · Supplement 36AP
1999-02-05Manufacturing (CMC) · Supplement 35AP
1998-05-29Manufacturing (CMC) · Supplement 34AP
1996-11-29Manufacturing (CMC) · Supplement 32AP
1996-03-18Manufacturing (CMC) · Supplement 31AP
1995-08-30Labeling · Supplement 29 · standardAP
1995-05-18Manufacturing (CMC) · Supplement 30AP
1992-09-17Manufacturing (CMC) · Supplement 10AP
1992-02-03Manufacturing (CMC) · Supplement 13AP
1988-03-22Manufacturing (CMC) · Supplement 9AP
1987-06-30Labeling · Supplement 7AP
1987-06-30Manufacturing (CMC) · Supplement 6AP
1987-05-15Labeling · Supplement 8AP
1984-07-25Manufacturing (CMC) · Supplement 5AP
1984-04-23Manufacturing (CMC) · Supplement 4AP
1983-12-30Labeling · Supplement 3AP
1983-11-23Manufacturing (CMC) · Supplement 2AP
1983-07-11Manufacturing (CMC) · Supplement 1AP
1983-07-11Manufacturing (CMC) · Supplement 28AP
1982-07-29Labeling · Supplement 27AP
1981-06-17Manufacturing (CMC) · Supplement 26AP
1981-04-13Manufacturing (CMC) · Supplement 25AP
1978-05-10Labeling · Supplement 24AP
1973-02-20Manufacturing (CMC) · Supplement 23AP
1973-02-08Manufacturing (CMC) · Supplement 21AP
1973-02-08Manufacturing (CMC) · Supplement 22AP
1972-09-19Labeling · Supplement 20AP
VIEW ON DRUGS@FDA ↗

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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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