Orange Book product · Brand (NDA)
KLOXXADO
NALOXONE HYDROCHLORIDE
At a glance
Aug 25, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 25, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
NALOXONE HYDROCHLORIDE
Strength
4MG/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 212045
Product number
002
Marketing status
RX
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.
