Epipen, Epipen Jr., Epipen E Z Pen

Treats allergic reactions (Type I) including anaphylaxis. NDA 19430, held by Viatris. Epinephrine.

As of Nov 14, 2026, NDA 19430 (Epipen, Epipen Jr., Epipen E Z Pen), held by Viatris, was first approved by FDA on Dec 22, 1987, with 34 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1987
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Dec 22, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Epipen0.3MG/DELIVERY · injectable;intramuscular, subcutaneous	Epinephrine	RxReference drug
Epipen Jr.0.15MG/DELIVERY · injectable;intramuscular, subcutaneous	Epinephrine	RxReference drug
Epipen E Z Pen0.3MG/DELIVERY · injectable;intramuscular	Epinephrine	Discontinued
Epi E Z Pen Jr0.15MG/DELIVERY · injectable;intramuscular	Epinephrine	Discontinued

All 35 submissions, including labeling and manufacturing supplements


Mar 20, 2026	Supplement 120Manufacturing	Approved	Label Letter
Feb 10, 2023	Supplement 106Labeling · Standard review	Approved	Letter Label
Dec 24, 2020	Supplement 91Labeling · Standard review	Approved	Letter Label
Jun 17, 2020	Supplement 89Labeling · Standard review	Approved	Label Letter
Jan 31, 2020	Supplement 82Labeling · Standard review	Approved	Letter Label
Aug 23, 2018	Supplement 74Labeling · Standard review	Approved	Label Letter
Apr 28, 2017	Supplement 67Labeling · Standard review	Approved	Label Letter
May 18, 2016	Supplement 61Labeling	Approved	Review Letter Label
Mar 3, 2016	Supplement 60Manufacturing · Standard review	Approved	None posted
Jul 17, 2014	Supplement 58Labeling · Standard review	Approved	Label Letter
Apr 30, 2014	Supplement 59Labeling · Standard review	Approved	Review Label Letter
Dec 13, 2013	Supplement 57Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 56Manufacturing · Standard review	Approved	Review
Sep 16, 2013	Supplement 55Manufacturing · Standard review	Approved	Review
Jul 23, 2013	Supplement 54Manufacturing · Standard review	Approved	Review
Aug 20, 2012	Supplement 53Labeling · Standard review	Approved	Letter Label
May 19, 2009	Supplement 47Labeling · Standard review	Approved	Letter
Sep 26, 2008	Supplement 44Labeling · Standard review	Approved	Label Letter
Dec 17, 2003	Supplement 25Labeling · Standard review	Approved	Letter
Dec 19, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 21, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 28, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 16, 2002	Supplement 15Manufacturing · Standard review	Approved	Review
Feb 20, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 27, 2001	Supplement 12Labeling · Standard review	Approved	Label
Jan 11, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
May 11, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 15, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 5, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
May 25, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 24, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 25, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 2, 1989	Supplement 1Labeling	Approved	Review
Dec 22, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19430
Drugs@FDA: Overview at FDA
Company: Viatris

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