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 3 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 Method Pharmaceuticals, LLC 733d6e32-ac90-4796-bf25-9d5887c897a5 2025-12-23 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 99a715a0-4579-410c-b102-7ef6fab8db55 2025-12-19 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Redpharm Drug 32525ed4-3cca-2b99-e063-6294a90a6c66 2025-12-13 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Chartwell RX, LLC ac439c08-1e47-4306-8308-b31d7a1a443c 2025-12-02 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Mullan Pharmaceutical Inc. fb5ef3ba-0a7e-4f41-9547-d734983da0d3 2025-12-01 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE A-S Medication Solutions e6836a01-220d-4b69-9b4a-c919daeb6ece 2025-11-20 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 0dcd514d-bda8-484b-8cf1-f5656aaab9ce 2025-10-29 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 20c26652-52da-4eef-8486-f91eb30e9ff7 2025-10-29 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack dafa7411-2857-4f5a-a587-4367cfbe2bfa 2025-10-23 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE Amneal Pharmaceuticals LLC dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc 2025-10-06 Warnings, Adverse reactions Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Macleods Pharmaceuticals Limited 366134cd-6244-45fc-99f1-0193a0221b3a 2025-10-06 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE RedPharm Drug 1e1b7355-4802-d277-e063-6394a90aef44 2025-07-29 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE NuCare Pharmaceuticals , Inc. 3aff731f-1eec-19b5-e063-6294a90a3143 2025-07-28 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol HCL LABETALOL HYDROCHLORIDE A-S Medication Solutions 312dde0d-5147-483e-968f-4e0d46114176 2025-06-19 Warnings, Adverse reactions Name fallback generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Caplin Steriles Limited 77152699-1ca8-442a-8cb4-80b0ffbec6f2 2025-02-14 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE A-S Medication Solutions 5faacbcc-f88f-42f7-8702-791ee82c4d18 2025-01-09 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE American Health Packaging 3004aa59-288c-4971-b77b-78789715ef5a 2024-12-30 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Zydus Lifesciences Limited a3c0cc1e-1c01-4009-afdc-d35a66546aec 2024-11-30 Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL HYDROCHLORIDE Bryant Ranch Prepack 64cd636d-8b48-4f29-b41d-4a048335793e 2024-11-20 Warnings, Adverse reactions Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE Labetalol Hydrochloride LABETALOL Marlex Pharmaceuticals Inc 28c91727-e5a8-48b3-a4df-d7bec8feda40 2024-10-07 Warnings, Adverse reactions Name fallback brand 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