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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

CSV Excel Print

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

Showing 1 to 2 of 2 entries

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

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
06/15/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review

Showing 1 to 1 of 1 entries

Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/29/2021	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)
08/26/2020	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.
09/27/2018	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)

Showing 1 to 3 of 3 entries

Labels for NDA 207534

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/29/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)
06/29/2021	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)
06/29/2021	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)
09/27/2018	SUPPL-3	Efficacy-New Patient Population	Label (PDF)
06/15/2017	ORIG-1	Approval	Label (PDF)

Showing 1 to 5 of 5 entries

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