← FDA DRUG APPROVALS

FDA NDA · NDA016466

ARISTOSPAN

Sponsor: ETHYPHARM

APPLICATION
NDA016466
TYPE
NDA
ORIGINAL APPROVAL
1969-07-29
LATEST ACTION
2024-06-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ARISTOSPAN · ReferenceDiscontinued
TRIAMCINOLONE HEXACETONIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ARISTOSPAN · ReferenceDiscontinued
TRIAMCINOLONE HEXACETONIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-06-05Labeling · Supplement 47 · standard — Label ↗AP
2014-09-04Manufacturing (CMC) · Supplement 45 · standard — Review ↗AP
2014-07-03Labeling · Supplement 46 · standard — Label ↗AP
2009-06-03Labeling · Supplement 40 · standard — Letter ↗AP
2009-06-03Labeling · Supplement 41 · standard — Letter ↗AP
2007-03-01Labeling · Supplement 36 · standard — Letter ↗AP
2006-02-01Labeling · Supplement 27 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 32 · standard — Review ↗AP
1999-10-25Manufacturing (CMC) · Supplement 31 · standardAP
1996-01-18Manufacturing (CMC) · Supplement 30 · standardAP
1995-09-08Manufacturing (CMC) · Supplement 29 · standardAP
1994-08-04Manufacturing (CMC) · Supplement 28 · standardAP
1993-09-07Labeling · Supplement 26AP
1992-01-06Manufacturing (CMC) · Supplement 25 · standardAP
1991-11-26Manufacturing (CMC) · Supplement 23 · standardAP
1990-05-30Manufacturing (CMC) · Supplement 21 · standardAP
1985-06-12Labeling · Supplement 17AP
1980-10-07Manufacturing (CMC) · Supplement 15 · standardAP
1979-04-18Manufacturing (CMC) · Supplement 13 · standardAP
1979-04-18Labeling · Supplement 11AP
1979-04-13Labeling · Supplement 12AP
1978-08-04Manufacturing (CMC) · Supplement 14 · standardAP
1969-07-29Type 2 - New Active Ingredient · 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 →