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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207534
Company: ADAMIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMJEPI EPINEPHRINE 0.3MG/0.3ML (0.3MG/0.3ML) SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS Prescription None Yes Yes
SYMJEPI EPINEPHRINE 0.15MG/0.3ML (0.15MG/0.3ML) SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207534lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207534Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207534Orig1s0000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2021 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207534s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207534Orig1s012ltr.pdf
08/26/2020 SUPPL-8 Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207534Orig1s008ltr.pdf
09/27/2018 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207534s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207534Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2021 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207534s012lbl.pdf
06/29/2021 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207534s012lbl.pdf
06/29/2021 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207534s012lbl.pdf
09/27/2018 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207534s003lbl.pdf
06/15/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207534lbl.pdf
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