Home Applications 076057 Application 076057
Type ANDA
Sponsor BARR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE TABLET;ORAL 400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076057-001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26
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 · 41 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 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL 2001-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076057-001 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2001-11-26 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE REMEDYREPACK INC. c12b3482-55f0-4324-bdcd-b129ca2dae73 2026-07-31 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE STI Pharma LLC 3f6428d6-3745-4337-ad78-ebfff9f49135 2026-05-05 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE REMEDYREPACK INC. e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a 2026-04-23 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE Kanchan Healthcare Inc e4ccab0e-84ff-447f-82ca-fa0a3989f6b7 2025-11-21 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE Lupin Pharmaceuticals, Inc. c732b415-e1f9-478f-896d-1dc8b6362da4 2025-10-22 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE American Health Packaging d32e9865-8edd-4644-9939-62ed119db3ef 2025-09-18 Warnings, Adverse reactions Name fallback brand name: Ethambutol Hydrochloride generic name: ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Marlex Pharmaceuticals, Inc. 1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1 2025-08-22 Warnings, Adverse reactions Name fallback brand name: ETHAMBUTOL HYDROCHLORIDE generic name: ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC 08decdf3-a397-42e7-8ac3-e489c0cc7085 2023-11-08 Warnings, Adverse reactions Name fallback brand name: ETHAMBUTOL HYDROCHLORIDE generic name: ETHAMBUTOL HYDROCHLORIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0555-0923 Ethambutol Hydrochloride Ethambutol Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0923 Ethambutol Hydrochloride Ethambutol Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0923 Ethambutol Hydrochloride Ethambutol Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0923 Ethambutol Hydrochloride Ethambutol Hydrochloride Teva Pharmaceuticals USA, Inc. ANDA Current 70518-0751 Ethambutol Hydrochloride Ethambutol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-0751 Ethambutol Hydrochloride Ethambutol Hydrochloride REMEDYREPACK INC. ANDA Current 70518-0751 Ethambutol Hydrochloride Ethambutol Hydrochloride REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8856 ORIG 2003-04-16