Home Applications 078962 Application 078962
Type ANDA
Sponsor KVK TECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE TABLET;ORAL 10MG No No 002 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078962-001 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 A078962-002 BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078962-001 BETAXOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078962-002 BETAXOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2008-06-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10702-013 BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride KVK-TECH, INC. ANDA Current 10702-013 BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride KVK-TECH, INC. ANDA Current 10702-014 BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride KVK-TECH, INC. ANDA Current 10702-014 BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride KVK-TECH, INC. ANDA Current 60429-753 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-753 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-753 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-753 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-753 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-754 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-754 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current 60429-754 Betaxolol Betaxolol Golden State Medical Supply, Inc. ANDA Current