Home Applications 079134 Application 079134
Type ANDA
Sponsor MYLAN ASI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE INJECTABLE;INJECTION 5MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079134-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2010-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2010-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A079134-001 AP 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079134-001 AP 1 ea99ee380514…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.