Home Applications 075431 Application 075431
Type ANDA
Sponsor AKORN INC 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 43 .
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 A075431-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075431-001 AP
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 · 43 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 2026-09-14 22:38:34 2026-08 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075431-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-11-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 2 of 5 · 83 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE REMEDYREPACK INC. ae5d7b3b-e444-48d3-9d85-9b07319f9374 2026-04-10 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Advagen Pharma Ltd 106a0959-5830-489f-ba60-afd4eb0fac36 2026-04-02 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Advagen Pharma Ltd 1c680447-b43a-4ff1-bc64-2c2174ca1c9a 2026-04-02 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions d4364caf-46c6-4144-9ba5-2c561e4f3a95 2026-03-26 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 3909ac9e-6818-4c5d-ad0e-52865a574b45 2026-03-25 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 35e7bce0-d9ff-4f8b-95c5-218da2a2d929 2026-03-25 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack f7f7fade-98a6-4741-bfb9-f1eb54ad4565 2026-03-25 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions d207396a-068e-4229-88cc-a1a4df7aeff2 2026-03-07 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions b4a5f170-a400-4986-8c64-f55d0413f0f6 2026-03-07 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. bf84ebae-3c91-4448-b1db-8e5ed3053866 2026-03-05 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Major Pharmaceuticals 35b5fd32-581d-427b-9a13-b7a02846d21d 2026-03-03 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Civica, Inc. d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8 2026-03-03 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Zydus Pharmaceuticals USA Inc. 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8 2026-03-02 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Unichem Pharmaceuticals (USA), Inc. ed0188ba-3fd3-4680-a829-ba242a115fab 2026-02-25 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Biocon Pharma Inc. 27e4ab03-c17b-4268-912c-e45a5e8f8dd8 2026-02-19 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 0db22a64-1863-4188-850b-273ea746e327 2026-02-09 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack d8b69cc9-bdee-4e24-a3d8-d1887de5a17d 2026-02-06 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 6f919513-500e-4a05-935e-b6fc1615368a 2026-01-29 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Northwind Health Company, LLC faf7a1ff-f18a-8ca7-e053-6394a90a1b1f 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Innogenix, Inc. 82fc2d64-0572-4a9b-94fc-f6eb8d930c54 2025-12-23 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-420 Labetalol Hydrochloride Labetalol Hydrochloride Akorn, Inc. ANDA Current 17478-420 Labetalol Hydrochloride Labetalol Hydrochloride Akorn, Inc. ANDA Current 17478-420 Labetalol Hydrochloride Labetalol Hydrochloride Akorn ANDA Current 17478-420 Labetalol Hydrochloride Labetalol Hydrochloride Akorn, Inc. ANDA Current 17478-420 Labetalol Hydrochloride Labetalol Hydrochloride Akorn ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30883 ORIG 1999-12-29