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 43 .
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 · 129 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 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 · 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