Orange Book product · Brand (NDA)
ADRENACLICK
EPINEPHRINE
At a glance
Nov 25, 2009
Approved
Brand (NDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 2009
16 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINEPHRINE
Strength
EQ 0.3MG/DELIVERY
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, SUBCUTANEOUS
TE code
BX
Application
NDA 020800
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026EPINEPHRINEBrand (NDA)
NDA 220626 · BAXTER HLTHCARE CORP
- 2025EPINEPHRINEBrand (NDA)
NDA 215425 · FRESENIUS KABI USA
- 2025NEFFYBrand (NDA)
NDA 214697 · ARS PHARMS OPERATION
- 2024EPINEPHRINEBrand (NDA)
NDA 205029 · BPI LABS
- 2023ADRENALINBrand (NDA)
NDA 215875 · PH HEALTH
- 2022EPINEPHRINEBrand (NDA)
NDA 211363 · INTL MEDICATION SYS
- 2019EPINEPHRINEBrand (NDA)
NDA 209359 · HOSPIRA
- 2018PRIMATENE MISTBrand (NDA)
NDA 205920 · ARMSTRONG PHARMS
- 2018SYMJEPIBrand (NDA)
NDA 207534 · ADAMIS PHARMS CORP
- 2017AUVI-QBrand (NDA)
NDA 201739 · KALEO INC
- 2013ADRENALINBrand (NDA)
NDA 204640 · PH HEALTH
- 2012ADRENALINBrand (NDA)
NDA 204200 · PH HEALTH
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
