Tools / Drug approvals and letters / Drugs Atropen Treats poisoning. NDA 17106, held by Mmt . Atropine
As of Nov 13, 2026, NDA 17106 (Atropen), held by Mmt, was first approved by FDA on May 15, 1973, with 32 approved supplements and 0 published complete response letters.
First approved : May 15, 1973 Review : Priority Supplements approved : 32 Complete response letters : 0
What It's For From the FDA-approved label (Indications and Usage) ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.
Full prescribing information on DailyMed ↗
Approvals and New Uses The original application and every efficacy supplement, newest first; all 33 submissions below Date Submission Status Documents Jun 19, 2003 Supplement 28Efficacy (new indication or use) · Priority review Approved Letter Label May 15, 1973 Original applicationNew formulation or manufacturer · Priority review Approved None posted
Products 4 strengths and forms Product Active ingredient Marketing AtropenEQ 2MG SULFATE/0.7ML · solution;intramuscular Atropine Discontinued Reference drug AtropenEQ 1MG SULFATE/0.7ML · solution;intramuscular Atropine Discontinued Reference drug AtropenEQ 0.5MG SULFATE/0.7ML · solution;intramuscular Atropine Discontinued Reference drug AtropenEQ 0.25MG SULFATE/0.3ML · solution;intramuscular Atropine Discontinued Reference drug
All 33 submissions, including labeling and manufacturing supplements Date Submission Status Documents Nov 20, 2020 Supplement 52Labeling · Standard review Approved Letter Label May 27, 2016 Supplement 49Manufacturing · Priority review Approved None posted Aug 10, 2015 Supplement 51Manufacturing · Priority review Approved None posted Nov 14, 2013 Supplement 45Manufacturing · Priority review Approved None posted Sep 17, 2004 Supplement 32Manufacturing · Priority review Approved Letter Label Jun 19, 2003 Supplement 28Efficacy (new indication or use) · Priority review Approved Letter Label Jun 28, 2002 Supplement 27Manufacturing · Priority review Approved None posted Mar 4, 2002 Supplement 25Manufacturing · Priority review Approved None posted Jan 7, 2002 Supplement 26Manufacturing · Priority review Approved None posted Jun 8, 2001 Supplement 24Manufacturing · Priority review Approved None posted Feb 13, 2001 Supplement 23Manufacturing · Priority review Approved None posted Jan 31, 2001 Supplement 22Manufacturing · Priority review Approved None posted Oct 19, 2000 Supplement 21Manufacturing · Priority review Approved None posted Aug 18, 2000 Supplement 19Manufacturing · Priority review Approved None posted Aug 16, 2000 Supplement 20Manufacturing · Priority review Approved None posted Oct 28, 1999 Supplement 18Manufacturing · Priority review Approved None posted Apr 26, 1999 Supplement 17Manufacturing · Priority review Approved None posted Mar 16, 1999 Supplement 16Manufacturing · Priority review Approved None posted Aug 25, 1998 Supplement 15Manufacturing · Priority review Approved None posted Apr 21, 1998 Supplement 14Labeling · Standard review Approved None posted Mar 6, 1997 Supplement 13Manufacturing · Priority review Approved None posted Dec 17, 1996 Supplement 12Manufacturing · Priority review Approved None posted Mar 5, 1991 Supplement 11Manufacturing · Priority review Approved None posted Aug 17, 1990 Supplement 10Manufacturing · Priority review Approved None posted Apr 4, 1989 Supplement 9Manufacturing · Priority review Approved None posted Aug 19, 1987 Supplement 8Manufacturing · Priority review Approved None posted Oct 6, 1986 Supplement 7Manufacturing · Priority review Approved None posted Jan 14, 1985 Supplement 6Manufacturing · Priority review Approved None posted Jun 6, 1984 Supplement 5Labeling Approved None posted Dec 27, 1979 Supplement 4Manufacturing · Priority review Approved None posted May 10, 1979 Supplement 3Manufacturing · Priority review Approved None posted Jul 27, 1978 Supplement 1Manufacturing · Priority review Approved None posted May 15, 1973 Original applicationNew formulation or manufacturer · Priority review Approved None posted
Identifiers
Application NDA 17106 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
