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FDA NDA · NDA207534

SYMJEPI

Sponsor: ADAMIS PHARMS CORP

APPLICATION
NDA207534
TYPE
NDA
ORIGINAL APPROVAL
2017-06-15
LATEST ACTION
2021-06-29
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

SYMJEPI · ReferencePrescription
EPINEPHRINE 0.3MG/0.3ML (0.3MG/0.3ML) · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS
SYMJEPI · ReferenceDiscontinued
EPINEPHRINE 0.15MG/0.3ML (0.15MG/0.3ML) · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2021-06-29Labeling · Supplement 12 · standard — Letter ↗AP
2020-08-26Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-27Efficacy · Supplement 3 · standard — Letter ↗AP
2017-06-15Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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