Orange Book product · Brand (NDA)

SYMJEPI

EPINEPHRINE

Brand (NDA)NDA 207534DISCN ADAMIS PHARMS CORP

Sep 27, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 27, 2018
7 yr 10 mo ago
Today
Patent 11141540 expires
Listed drug product patent expiration.
Oct 20, 2036
in 10 yr 6 mo

Active ingredient

EPINEPHRINE

Strength

0.15MG/0.3ML (0.15MG/0.3ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

Not listed

Application

NDA 207534

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11141540	Oct 20, 2036	in 10 yr 6 mo	ProductU-3379