← FDA DRUG APPROVALS

FDA NDA · NDA014602

CELESTONE SOLUSPAN

betamethasone acetate and betamethasone sodium phosphate

Sponsor: ORGANON

APPLICATION
NDA014602
TYPE
NDA
ORIGINAL APPROVAL
1965-03-03
LATEST ACTION
2024-07-08
ROUTE
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, SOFT TISSUE, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CELESTONE SOLUSPAN · ReferencePrescription
BETAMETHASONE ACETATE 3MG/ML, BETAMETHASONE SODIUM PHOSPHATE EQ 3MG BASE/ML · INJECTABLE · INJECTION

Approval history

2024-07-08Labeling · Supplement 64 · standard — Letter ↗AP
2024-06-05Labeling · Supplement 68 · standard — Label ↗AP
2022-09-06Labeling · Supplement 65 · standard — Letter ↗AP
2018-04-10Labeling · Supplement 62 · standard — Label ↗AP
2018-02-09Labeling · Supplement 61 · standard — Label ↗AP
2015-02-04Labeling · Supplement 59 · standard — Label ↗AP
2014-07-03Labeling · Supplement 58 · standard — Letter ↗AP
2014-05-21Manufacturing (CMC) · Supplement 57 · standardAP
2013-03-13Manufacturing (CMC) · Supplement 56 · standard — Review ↗AP
2013-01-09Manufacturing (CMC) · Supplement 55 · standardAP
2008-06-24Labeling · Supplement 47 · standard — Letter ↗AP
2006-07-12Labeling · Supplement 19 · standard — Letter ↗AP
2001-07-24Manufacturing (CMC) · Supplement 25 · standardAP
2000-04-10Manufacturing (CMC) · Supplement 24 · standardAP
1999-10-08Manufacturing (CMC) · Supplement 23 · standardAP
1999-07-15Manufacturing (CMC) · Supplement 22 · standardAP
1997-07-21Manufacturing (CMC) · Supplement 21 · standardAP
1996-11-13Manufacturing (CMC) · Supplement 20 · standardAP
1995-05-03Manufacturing (CMC) · Supplement 18 · standardAP
1994-04-13Labeling · Supplement 17 · standardAP
1994-03-14Manufacturing (CMC) · Supplement 16 · standardAP
1993-09-07Labeling · Supplement 15 · standardAP
1992-12-17Labeling · Supplement 14AP
1992-02-06Manufacturing (CMC) · Supplement 13 · standardAP
1990-05-01Manufacturing (CMC) · Supplement 11 · standardAP
1987-07-01Manufacturing (CMC) · Supplement 12 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 10 · standardAP
1982-11-04Manufacturing (CMC) · Supplement 8 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 9 · standardAP
1979-08-08Labeling · Supplement 6AP
1965-03-03Type 1 - New Molecular Entity · 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 →