Orange Book product · Brand (NDA)
NARCAN
NALOXONE HYDROCHLORIDE
At a glance
Jan 24, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2017
9 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NALOXONE HYDROCHLORIDE
Strength
2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 208411
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2024NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213573 · FRESENIUS KABI USA
- 2024NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212300 · HIKMA
- 2023NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 216977 · BPI LABS
- 2022NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 214792 · BAXTER HLTHCARE CORP
- 2022NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 216624 · ACCORD HLTHCARE
- 2021NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 214785 · BAXTER HLTHCARE CORP
- 2021NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213279 · EUGIA PHARMA
- 2020NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213209 · DR REDDYS
- 2019NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212456 · EUGIA PHARMA
- 2019NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212455 · EUGIA PHARMA
- 2018NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207846 · CHARTWELL RX
- 1989NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 072081 · ASTRAZENECA
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.
