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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207534
Company: ADAMIS PHARMS CORP

Products on NDA 207534

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	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207534

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-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	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-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient 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

Labels for NDA 207534

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
06/29/2021	SUPPL-12	Labeling-Container/Carton Labels	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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