Orange Book product · Brand (NDA)
TRANDATE
LABETALOL HYDROCHLORIDE
At a glance
May 24, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 1985
41 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
LABETALOL HYDROCHLORIDE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018716
Product number
001
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.
- 2022LABETALOL HYDROCHLORIDEBrand (NDA)
NDA 213330 · HIKMA
- 1987NORMODYNEBrand (NDA)
NDA 018687 · SCHERING
- 1985TRANDATEBrand (NDA)
NDA 019425 · SEBELA IRELAND LTD
- 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
- 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.
