Deltasone

NDA 9986, held by Pharmacia And Upjohn. Prednisone.

As of Nov 13, 2026, NDA 9986 (Deltasone), held by Pharmacia And Upjohn, was first approved by FDA on Jun 21, 1955, with 20 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1955
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jun 21, 1955	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Deltasone5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Prednisone	DiscontinuedReference drug
Deltasone2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Prednisone	DiscontinuedReference drug
Deltasone10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Prednisone	DiscontinuedReference drug
Deltasone20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Prednisone	DiscontinuedReference drug
Deltasone50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Prednisone	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 35Labeling	Approved	None posted
Mar 13, 2009	Supplement 40Labeling	Approved	None posted
Mar 13, 2009	Supplement 47Labeling	Approved	None posted
Mar 13, 2009	Supplement 50Labeling	Approved	None posted
Mar 13, 2009	Supplement 51Labeling	Approved	None posted
Mar 13, 2009	Supplement 54Labeling	Approved	None posted
Mar 13, 2009	Supplement 57Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 58Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 59Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 60Labeling · Standard review	Approved	None posted
Dec 28, 1993	Supplement 55Labeling	Approved	None posted
May 24, 1993	Supplement 56Manufacturing · Standard review	Approved	None posted
Apr 6, 1989	Supplement 52Manufacturing · Standard review	Approved	None posted
May 20, 1985	Supplement 49Manufacturing · Standard review	Approved	None posted
Jan 9, 1985	Supplement 48Labeling	Approved	None posted
Jul 23, 1979	Supplement 45Manufacturing · Standard review	Approved	None posted
Apr 25, 1979	Supplement 44Manufacturing · Standard review	Approved	None posted
Jan 17, 1979	Supplement 43Manufacturing · Standard review	Approved	None posted
Oct 18, 1978	Supplement 42Labeling	Approved	None posted
Jul 20, 1977	Supplement 41Manufacturing · Standard review	Approved	None posted
Jun 21, 1955	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 9986
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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