Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207534

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SYMJEPI (EPINEPHRINE)
0.3MG/0.3ML (0.3MG/0.3ML)
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: SYMJEPI
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: 0.3MG/0.3ML (0.3MG/0.3ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207534
Product Number: 001
Approval Date: Jun 15, 2017
Applicant Holder Full Name: ADAMIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMJEPI (EPINEPHRINE)
0.15MG/0.3ML (0.15MG/0.3ML)
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE
Proprietary Name: SYMJEPI
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: 0.15MG/0.3ML (0.15MG/0.3ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207534
Product Number: 002
Approval Date: Sep 27, 2018
Applicant Holder Full Name: ADAMIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information