Orange Book product · Brand (NDA)
PRIMATENE MIST
EPINEPHRINE
At a glance
Nov 07, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 2018
7 yr 9 mo ago
Patent 8367734 expires
Listed drug product patent expiration.
Jan 26, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINEPHRINE
Strength
0.125MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 205920
Product number
001
Marketing status
OTC
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
- 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
- 2009ADRENACLICKBrand (NDA)
NDA 020800 · IMPAX
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8367734 | Jan 26, 2026 | 5 mo ago | Product |
