← FDA DRUG APPROVALS

FDA NDA · NDA050616

TOBRADEX

tobramycin and dexamethasone

Sponsor: NOVARTIS

APPLICATION
NDA050616
TYPE
NDA
ORIGINAL APPROVAL
1988-09-28
LATEST ACTION
2021-05-14
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

TOBRADEX · ReferencePrescription
DEXAMETHASONE 0.1%, TOBRAMYCIN 0.3% · OINTMENT · OPHTHALMIC

Approval history

2021-05-14Labeling · Supplement 41 · standard — Letter ↗AP
2021-05-14Labeling · Supplement 40 · standard — Letter ↗AP
2020-04-24Labeling · Supplement 39 · standard — Letter ↗AP
2004-07-15Labeling · Supplement 21 · standard — Label ↗AP
2004-07-15Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP
2003-03-18Labeling · Supplement 19 · standard — Label ↗AP
2003-03-18Labeling · Supplement 17 · standard — Label ↗AP
2003-03-18Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2002-12-11Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
1999-09-28Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
1999-04-28Labeling · Supplement 11 · standard — Review ↗AP
1999-04-07Manufacturing (CMC) · Supplement 14 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 13 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 12 · standardAP
1996-11-29Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
1996-09-26Labeling · Supplement 9 · standard — Review ↗AP
1996-03-18Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1994-10-27Labeling · Supplement 7 · standard — Review ↗AP
1993-08-31Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1992-09-17Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1992-05-21Labeling · Supplement 5 — Review ↗AP
1992-02-03Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1989-06-27Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1988-09-28Type 3 - New Dosage Form · Original · standardAP
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 →