Celestone

NDA 14215, held by Merck Sharp Dohme. Betamethasone.

As of Nov 14, 2026, NDA 14215 (Celestone), held by Merck Sharp Dohme, was first approved by FDA on Apr 13, 1964, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 13, 1964
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Apr 13, 1964	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Celestone0.6MG/5ML · syrup;oral	Betamethasone	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Jul 12, 2006	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 12, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 27, 2000	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 8, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 16, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 19, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 27, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
May 4, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 2, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 10, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 10, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 13, 1994	Supplement 13Labeling · Standard review	Approved	None posted
Sep 7, 1993	Supplement 11Labeling · Standard review	Approved	None posted
Dec 17, 1992	Supplement 10Labeling · Standard review	Approved	None posted
Apr 19, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 10, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 30, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 12, 1978	Supplement 4Labeling · Standard review	Approved	None posted
Apr 13, 1964	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 14215
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

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