FDA Orange Book · active-ingredient family
Labetalol hydrochloride
Labetalol hydrochloride is approved as 5 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LABETALOL HYDROCHLORIDE · NDA 213330
5
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDERLD×6 | HIKMA | NDA 213330 | — | Mar 18, 2022 | |
| NORMODYNERLD×4 | SCHERING | NDA 018687 | — | Aug 31, 1987 | |
| TRANDATERLD | SEBELA IRELAND LTD | NDA 019425 | — | Dec 31, 1985 | |
| TRANDATERLD×4 | ALVOGEN | NDA 018716 | — | May 24, 1985 | |
| NORMODYNERLD | SCHERING | NDA 018686 | — | Aug 01, 1984 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | AMNEAL | ANDA 218870 | AP | Oct 02, 2025 | |
| LABETALOL HYDROCHLORIDE×3 | MACLEODS PHARMS LTD | ANDA 217949 | AB | Sep 23, 2025 | |
| LABETALOL HYDROCHLORIDE×3 | UNICHEM | ANDA 212719 | — | Aug 08, 2022 | |
| LABETALOL HYDROCHLORIDE | CAPLIN | ANDA 214533 | AP | Sep 07, 2021 | |
| LABETALOL HYDROCHLORIDE×3 | RUBICON RESEARCH | ANDA 211953 | AB | Aug 18, 2021 | |
| LABETALOL HYDROCHLORIDE×3 | EPIC PHARMA LLC | ANDA 212990 | AB | Sep 30, 2020 | |
| LABETALOL HYDROCHLORIDE×3 | CADILA PHARMS LTD | ANDA 211325 | AB | May 13, 2019 | |
| LABETALOL HYDROCHLORIDE×3 | HIBROW HLTHCARE | ANDA 207863 | AB | Feb 04, 2019 | |
| LABETALOL HYDROCHLORIDE×4 | APPCO | ANDA 209603 | AB | Jun 20, 2018 | |
| LABETALOL HYDROCHLORIDE×3 | ZYDUS PHARMS | ANDA 207743 | AB | Sep 19, 2017 | |
| LABETALOL HYDROCHLORIDE×3 | PH HEALTH | ANDA 200908 | AB | Jul 10, 2012 | |
| LABETALOL HYDROCHLORIDE | GLAND PHARMA LTD | ANDA 090699 | AP | Apr 03, 2012 | |
| LABETALOL HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 079134 | — | Feb 03, 2010 | |
| LABETALOL HYDROCHLORIDE | BAXTER HLTHCARE CORP | ANDA 076051 | AP | Jul 05, 2002 | |
| LABETALOL HYDROCHLORIDE | APOTHECON | ANDA 075355 | — | Nov 29, 1999 | |
| LABETALOL HYDROCHLORIDE | HOSPIRA | ANDA 075239 | AP | Nov 29, 1999 | |
| LABETALOL HYDROCHLORIDE | HOSPIRA | ANDA 075240 | AP | Nov 29, 1999 | |
| LABETALOL HYDROCHLORIDE | RISING | ANDA 075431 | AP | Nov 29, 1999 | |
| LABETALOL HYDROCHLORIDE | RISING | ANDA 075524 | — | Nov 29, 1999 | |
| LABETALOL HYDROCHLORIDE | HOSPIRA | ANDA 075242 | — | Sep 30, 1999 | |
| LABETALOL HYDROCHLORIDE×3 | ANDAS 5 HOLDING | ANDA 075215 | AB | Jul 29, 1999 | |
| LABETALOL HYDROCHLORIDE | HIKMA | ANDA 075303 | AP | May 28, 1999 | |
| LABETALOL HYDROCHLORIDE×3 | APOTHECON | ANDA 075223 | — | Nov 20, 1998 | |
| LABETALOL HYDROCHLORIDE×3 | TEVA | ANDA 074989 | — | Sep 30, 1998 | |
| LABETALOL HYDROCHLORIDE×3 | AIPING PHARM INC | ANDA 075113 | AB | Aug 04, 1998 | |
| LABETALOL HYDROCHLORIDE×4 | HERITAGE PHARMA | ANDA 074787 | AB | Aug 03, 1998 | |
| LABETALOL HYDROCHLORIDE×3 | WATSON LABS | ANDA 075133 | AB | Aug 03, 1998 |
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.
Labetalol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
