Orange Book product · Generic (ANDA)
LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE
At a glance
Oct 02, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 02, 2025
9 mo ago
Today
Pharmaceutical detail
Active ingredient
LABETALOL HYDROCHLORIDE
Strength
5MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 218870
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LABETALOL HYDROCHLORIDE
- 2022LABETALOL HYDROCHLORIDEBrand (NDA)
NDA 213330 · HIKMA
- 1987NORMODYNEBrand (NDA)
NDA 018687 · SCHERING
- 1985TRANDATEBrand (NDA)
NDA 019425 · SEBELA IRELAND LTD
- 1985TRANDATEBrand (NDA)
NDA 018716 · ALVOGEN
- 1984NORMODYNEBrand (NDA)
NDA 018686 · SCHERING
- 2025LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 217949 · MACLEODS PHARMS LTD
- 2022LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212719 · UNICHEM
- 2021LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 214533 · CAPLIN
- 2021LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211953 · RUBICON RESEARCH
- 2020LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212990 · EPIC PHARMA LLC
- 2019LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211325 · CADILA PHARMS LTD
- 2019LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207863 · HIBROW HLTHCARE
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.
