Home Applications 075113 Application 075113
Type ANDA
Sponsor SANDOZ 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 Yes 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 A075113-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 A075113-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 A075113-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04
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 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 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 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0010 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 0185-0010 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 0185-0117 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 0185-0117 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 0185-0118 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 0185-0118 Labetalol HCl Labetalol HCl Eon Labs, Inc. ANDA Current 51079-928 Labetalol HCl Labetalol HCl Mylan Institutional Inc. ANDA Current 51079-929 Labetalol HCl Labetalol HCl Mylan Institutional Inc. ANDA Current 55154-5485 Labetalol HCl Labetalol HCl Cardinal Health ANDA Current 55154-5485 Labetalol HCl Labetalol HCl Cardinal Health ANDA Current 60687-114 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60687-114 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60687-125 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60687-125 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60687-136 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60687-136 Labetalol HCl Labetalol HCl American Health Packaging ANDA Current 60760-610 Labetalol HCl Labetalol HCl St. Mary's Medical Park Pharmacy ANDA Current 63739-366 Labetalol HCl Labetalol HCl McKesson Corporation dba SKY Packaging ANDA Current 63739-366 Labetalol HCl Labetalol HCl McKesson Corporation ANDA Current 63739-366 Labetalol HCl Labetalol HCl McKesson Corporation dba SKY Packaging ANDA Current 68001-204 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 68001-204 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 68001-205 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 68001-205 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 68001-206 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 68001-206 Labetalol HCl Labetalol HCl BluePoint Laboratories ANDA Current 70518-0534 Labetalol HCl Labetalol HCl REMEDYREPACK INC. ANDA Current 70518-0534 Labetalol HCl Labetalol HCl REMEDYREPACK INC. ANDA Current 71335-0696 Labetalol HCl Labetalol HCl Bryant Ranch Prepack ANDA Current 71335-0696 Labetalol HCl Labetalol HCl Bryant Ranch Prepack ANDA Current 71335-0733 Labetalol HCl Labetalol HCl Bryant Ranch Prepack ANDA Current 71335-0733 Labetalol HCl Labetalol HCl Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30759 ORIG 1998-08-04