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Generated: November 17, 2018

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Details for New Drug Application (NDA): 207534

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NDA 207534 describes SYMJEPI, which is a drug marketed by Adamis Pharms Corp and is included in one NDA. It is available from one supplier. Additional details are available on the SYMJEPI profile page.

The generic ingredient in SYMJEPI is epinephrine. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 207534
Tradename:SYMJEPI
Applicant:Adamis Pharms Corp
Ingredient:epinephrine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207534
Suppliers and Packaging for NDA: 207534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMJEPI epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 207534 NDA Adamis Pharmaceuticals Corporation 38739-200 38739-200-06 6 CARTON in 1 CARTON (38739-200-06) > 1 SYRINGE in 1 CARTON (38739-200-01) > .3 mL in 1 SYRINGE
SYMJEPI epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 207534 NDA Adamis Pharmaceuticals Corporation 38739-200 38739-200-12 6 CARTON in 1 CARTON (38739-200-12) > 2 SYRINGE in 1 CARTON (38739-200-02) > .3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength0.3MG/0.3ML (0.3MG/0.3ML)
Approval Date:Jun 15, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength0.15MG/0.3ML (0.15MG/0.3ML)
Approval Date:Sep 27, 2018TE:RLD:Yes

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