Dopram

Prevents elevation of arterial CO2 tension during the administration of oxygen. NDA 14879, held by Hikma. Doxapram Hydrochloride.

As of Nov 13, 2026, NDA 14879 (Dopram), held by Hikma, was first approved by FDA on Jun 23, 1965, with 31 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1965
Review: Standard
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Postanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory depression or apnea other than that due to muscle relaxant drugs. To pharmacologically stimulate deep breathing in the postoperative patient. (A quantitative method of assessing oxygenation, such as pulse oximetry, is recommended.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jun 23, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dopram20MG/ML · injectable;injection	Doxapram Hydrochloride	RxReference drug

All 32 submissions, including labeling and manufacturing supplements


Mar 29, 2006	Supplement 37Labeling · Standard review	Approved	Letter
Mar 17, 2005	Supplement 44Labeling · Standard review	Approved	Review Letter Label
Apr 16, 2004	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 23, 2001	Supplement 36Labeling · Standard review	Approved	Letter
Feb 13, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
Jan 13, 1989	Supplement 34Manufacturing · Standard review	Approved	None posted
May 31, 1988	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 14, 1987	Supplement 31Labeling	Approved	None posted
Jan 14, 1987	Supplement 30Labeling	Approved	None posted
Jul 24, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 18, 1986	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 17, 1985	Supplement 25Labeling	Approved	None posted
May 16, 1984	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 2, 1983	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 6, 1982	Supplement 23Labeling	Approved	None posted
Aug 6, 1982	Supplement 22REMS · Standard review	Approved	None posted
Aug 6, 1982	Supplement 21Labeling	Approved	None posted
Aug 6, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 4, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 24, 1981	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 15, 1980	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 11, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 15, 1979	Supplement 15Labeling	Approved	None posted
Feb 15, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 30, 1978	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 27, 1978	Supplement 16Labeling	Approved	None posted
Jun 20, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 6, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 1, 1976	Supplement 8Manufacturing · Standard review	Approved	None posted
May 3, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 5, 1976	Supplement 7Labeling	Approved	None posted
Jun 23, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 14879
Drugs@FDA: Overview at FDA
Company: Hikma

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