Symjepi FDA Approval History
FDA Approved: Yes (First approved June 15, 2017)
Brand name: Symjepi
Generic name: epinephrine
Dosage form: Injection
Company: Adamis Pharmaceuticals Corporation
Treatment for: Allergic Reactions
Symjepi (epinephrine) is a non-selective alpha and betaadrenergic
receptor agonist in a single-dose, pre-filled syringe for use the emergency
treatment of allergic reactions (Type I) including anaphylaxis.
Development timeline for Symjepi
| Date | Article |
|---|
| Sep 27, 2018 | Approval Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product |
| Jun 15, 2017 | Approval Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe |
| Jan 19, 2017 | Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA |
| Dec 16, 2016 | Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA |
| Jun 6, 2016 | Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA |
| Jan 14, 2016 | Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA |
| Dec 7, 2015 | Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA |
| Aug 6, 2015 | Adamis Pharmaceuticals Provides Regulatory Update on Its Epinephrine Pre-Filled Syringe |
| Mar 27, 2015 | Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA |
| Jul 29, 2014 | FDA Accepts for Review Adamis’ New Drug Application for Its Epinephrine Pre-Filled Syringe |
| May 29, 2014 | Adamis Submits New Drug Application to FDA for Its Epinephrine Pre-Filled Syringe |
Further information
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Medical Disclaimer
