Celestone Soluspan

Controls severe or incapacitating allergic conditions. NDA 14602, held by Organon. Betamethasone Acetate; Betamethasone Sodium Phosphate.

As of Nov 13, 2026, NDA 14602 (Celestone Soluspan), held by Organon, was first approved by FDA on Mar 3, 1965, with 30 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1965
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of CELESTONE SOLUSPAN Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Mar 3, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Celestone Soluspan3MG/ML;EQ 3MG BASE/ML · injectable;injection	Betamethasone Acetate; Betamethasone Sodium Phosphate	RxReference drug

All 31 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 8, 2024	Supplement 64Labeling · Standard review	Approved	Letter Label
Jun 5, 2024	Supplement 68Labeling · Standard review	Approved	Letter Label
Sep 6, 2022	Supplement 65Labeling · Standard review	Approved	Label Letter
Apr 10, 2018	Supplement 62Labeling · Standard review	Approved	Letter Label
Feb 9, 2018	Supplement 61Labeling · Standard review	Approved	Letter Label
Feb 4, 2015	Supplement 59Labeling · Standard review	Approved	Letter Label
Jul 3, 2014	Supplement 58Labeling · Standard review	Approved	Letter Label
May 21, 2014	Supplement 57Manufacturing · Standard review	Approved	None posted
Mar 13, 2013	Supplement 56Manufacturing · Standard review	Approved	Review
Jan 9, 2013	Supplement 55Manufacturing · Standard review	Approved	None posted
Jun 24, 2008	Supplement 47Labeling · Standard review	Approved	Letter Label
Jul 12, 2006	Supplement 19Labeling · Standard review	Approved	Letter
Jul 24, 2001	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 10, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 15, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 21, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
May 3, 1995	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 13, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Mar 14, 1994	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 7, 1993	Supplement 15Labeling · Standard review	Approved	None posted
Dec 17, 1992	Supplement 14Labeling	Approved	None posted
Feb 6, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
May 1, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 1, 1987	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 10, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 4, 1982	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 30, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 8, 1979	Supplement 6Labeling	Approved	None posted
Mar 3, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 14602
Drugs@FDA: Overview at FDA
Company: Organon

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters