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Symjepi 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 History and FDA Approval Process for Symjepi

DateArticle
Sep 27, 2018Approval Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product
Jun 15, 2017Approval Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe
Jan 19, 2017Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
Dec 16, 2016Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA
Jun  6, 2016Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA
Jan 14, 2016Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
Dec  7, 2015Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA
Aug  6, 2015Adamis Pharmaceuticals Provides Regulatory Update on Its Epinephrine Pre-Filled Syringe
Mar 27, 2015Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA
Jul 29, 2014FDA Accepts for Review Adamis’ New Drug Application for Its Epinephrine Pre-Filled Syringe
May 29, 2014Adamis Submits New Drug Application to FDA for Its Epinephrine Pre-Filled Syringe

Further information

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