Home Applications 019270 Application 019270
Type NDA
Sponsor SANDOZ INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETOPTIC BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019270-001 BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019270-001 AT
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 2 · 43 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 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019270-001 BETOPTIC EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-08-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 N019270-001 AT 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019270-001 AT 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019270-001 AT 1 a50c72e98297…
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.
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61314-245 Betaxolol Hydrochloride Betaxolol Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 61314-245 Betaxolol Hydrochloride Betaxolol Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 61314-245 Betaxolol Hydrochloride Betaxolol Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 57630 ORIG 2019-02-15 33714 SUPPL 2006-02-22 1268 SUPPL 2006-02-22