Symjepi

NDA 207534, held by Adamis Pharms Corp. Epinephrine.

As of Nov 13, 2026, NDA 207534 (Symjepi), held by Adamis Pharms Corp, was first approved by FDA on Jun 15, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Sep 27, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 15, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Symjepi0.3MG/0.3ML (0.3MG/0.3ML) · solution;intramuscular, subcutaneous	Epinephrine	RxReference drug
Symjepi0.15MG/0.3ML (0.15MG/0.3ML) · solution;intramuscular, subcutaneous	Epinephrine	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Jun 29, 2021	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 26, 2020	Supplement 8Labeling · Standard review	Approved	Letter
Sep 27, 2018	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 15, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 207534
Drugs@FDA: Overview at FDA
Company: Adamis Pharmaceuticals

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