Orange Book product · Brand (NDA)
PRIMATENE MIST
EPINEPHRINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
EPINEPHRINE
Strength
0.2MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 016126
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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.
