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 4 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 Hikma Pharmaceuticals USA Inc. 5b059ef2-dec0-4cea-b8df-d87df3fea9e2 2024-09-06 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 94abdd54-a8e2-4858-8183-6c5d04dbceb5 2024-08-20 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 1fce27dd-90a6-45cf-9bd7-13147d3cc0d7 2024-08-12 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 706a877b-c388-43e7-b083-518111b288b0 2024-08-06 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 30f9fdef-8781-4327-9a8d-812cb31ff041 2024-07-10 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs 30280d40-28df-4c88-93bd-357a7c528906 2024-06-21 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 5a39bb96-4a60-49e8-859c-16bda0fe18e4 2024-06-05 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Gland Pharma Limited 48caf986-3126-48e1-afcd-16d65c9cfe00 2024-05-21 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Fosun Pharma USA Inc. 4a5ffab2-a3b8-411e-992d-7f38d508643a 2024-05-16 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions a007d945-417c-4647-ab03-95ca219d7d38 2024-05-01 Warnings, Adverse reactions Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 143ae21e-c350-4c92-b318-7537f4e46596 2024-04-08 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions 83a6e770-207a-46bc-992d-c1ad90d1006d 2023-10-30 Warnings, Adverse reactions Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE A-S Medication Solutions 1a71964e-e6fa-443e-bfdd-f8852f8cf29e 2023-10-26 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE A-S Medication Solutions c586ab65-56e8-4a4f-b471-902198d3e58c 2023-10-17 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE NorthStar Rx LLC a2d07ec0-3718-40eb-9d0a-79c557c486b9 2023-04-28 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Cadila Pharmaceuticals Limited 5fba93fc-4580-48c2-a1ec-5d446680adcf 2022-12-09 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol hydrochloride LABETALOL HYDROCHLORIDE Proficient Rx LP c0301841-e209-4242-bace-58a20e6dd01b 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE labetalol hydrochloride LABETALOL HYDROCHLORIDE Sagent Pharmaceuticals da8af6c2-d822-4ae5-9c2d-a1d161bdefd0 2022-04-12 Warnings, Adverse reactions Name fallback brand name: labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Epic Pharma, LLC b950655d-a9f8-4ace-bb56-0c7abbca231e 2021-09-30 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Hospira, Inc. d3579d45-a964-40fe-e3a2-a3a997c8b7b9 2021-05-28 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