Orange Book product · Generic (ANDA)
LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE
At a glance
Aug 18, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 18, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LABETALOL HYDROCHLORIDE
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211953
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 218870 · AMNEAL
- 2025LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 217949 · MACLEODS PHARMS LTD
- 2022LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212719 · UNICHEM
- 2021LABETALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 214533 · CAPLIN
- 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.
