Orange Book product · Generic (ANDA)
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE
At a glance
Jan 29, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 29, 2021
5 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NALOXONE HYDROCHLORIDE
Strength
0.4MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 214785
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NALOXONE HYDROCHLORIDE
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ANDA 213573 · FRESENIUS KABI USA
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ANDA 212300 · HIKMA
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ANDA 216977 · BPI LABS
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ANDA 214792 · BAXTER HLTHCARE CORP
- 2022NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 216624 · ACCORD HLTHCARE
- 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
- 1989NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 072082 · IGI LABS INC
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.
