Home Applications 207863 Application 207863
Type ANDA
Sponsor ATHEM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG No No 002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG No No 003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207863-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 A207863-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 A207863-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 1 of 5 · 86 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Hospira, Inc. abfc6b75-1ed5-41f1-0484-4597488237bc 2026-07-13 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE St. Mary's Medical Park Pharmacy 30281c4d-2fd1-167a-e063-6294a90a77c4 2026-06-30 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Onesource Specialty Pharma Limited 6cb2c117-584c-4440-acfb-e4b1af4dc509 2026-06-29 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE St. Mary's Medical Park Pharmacy ed2293f8-2b82-c3db-e053-2995a90ad46c 2026-06-22 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE REMEDYREPACK INC. 5101b8dd-6148-465c-9bba-0209ce823fe5 2026-06-11 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE BluePoint Laboratories Inc. 63ede355-42ec-4c52-a941-51e5f6b35ed6 2026-06-08 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 9c3bb751-c425-43ff-b530-2460b568b689 2026-06-05 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE A-S Medication Solutions fffb7c59-ad92-4e74-850d-d94d42b7fdc9 2026-06-04 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE BluePoint Laboratories e4562c70-f245-4dbe-8fe1-0bb64a91a315 2026-06-04 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Cardinal Health 107, LLC 1b96ddc9-d0c3-488a-a113-66491fd3d899 2026-06-03 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 04f9dcdf-4023-48ee-9e7d-ca9366d9db72 2026-05-22 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Cardinal Health 107, LLC d3ca153c-25b2-4506-91bd-bf9d6a4c01fe 2026-05-19 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack c0c1a162-cd30-4ac9-bc62-407493ed54a5 2026-05-11 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Proficient Rx LP 54b75509-824b-4291-818d-71dc1b88915f 2026-05-01 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Golden State Medical Supply, Inc. d5ce687f-4a37-d3e6-e053-2995a90aa974 2026-04-16 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions 371cb135-6a5f-433d-a87d-ab8521c4aa6d 2026-04-16 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions f9af85d3-a5a7-49d6-aff6-1ca2b2d75450 2026-04-16 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE NorthStar Rx LLC 5bd81a8a-a480-4c8d-bd4f-3158412e6a73 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 14803-502 Labetalol Hydrochloride Labetalol Hydrochloride ELYSIUM PHARMACEUTICALS LIMITED ANDA Current 14803-503 Labetalol Hydrochloride Labetalol Hydrochloride ELYSIUM PHARMACEUTICALS LIMITED ANDA Current 14803-504 Labetalol Hydrochloride Labetalol Hydrochloride ELYSIUM PHARMACEUTICALS LIMITED ANDA Current 50090-4917 Labetalol Hydrochloride Labetalol Hydrochloride A-S Medication Solutions ANDA Current 50090-4917 Labetalol Hydrochloride Labetalol Hydrochloride A-S Medication Solutions ANDA Current 63629-2053 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2053 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2054 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2054 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2055 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2055 Labetalol Hydrochloride Labetalol Hydrochloride Bryant Ranch Prepack ANDA Current 70518-2728 Labetalol Hydrochloride Labetalol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-2728 Labetalol Hydrochloride Labetalol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-2728 Labetalol Hydrochloride Labetalol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-2903 Labetalol Hydrochloride Labetalol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-2903 Labetalol Hydrochloride Labetalol Hydrochloride REMEDYREPACK INC. ANDA Current 70934-574 Labetalol Hydrochloride Labetalol Hydrochloride Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-751 Labetalol Hydrochloride Labetalol Hydrochloride Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71930-035 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-035 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-035 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-036 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-036 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-036 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-037 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-037 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current 71930-037 Labetalol Hydrochloride Labetalol Hydrochloride Eywa Pharma Inc ANDA Current