Home Applications 075095 Application 075095
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE TABLET;ORAL 100MG No No 002 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075095-001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 A075095-002 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30
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 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 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 42806-101 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 42806-101 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 42806-101 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 42806-102 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 42806-102 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 42806-102 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE Epic Pharma, LLC ANDA Current 50090-3948 Ethambutol Hydrochloride Ethambutol Hydrochloride A-S Medication Solutions ANDA Current 50090-3948 Ethambutol Hydrochloride Ethambutol Hydrochloride A-S Medication Solutions ANDA Current 61748-011 Ethambutol Hydrochloride Ethambutol Hydrochloride Versapharm Incorporated ANDA Current 61748-011 Ethambutol Hydrochloride Ethambutol Hydrochloride VersaPharm Inc. - An Akorn Company ANDA Current 61748-014 Ethambutol Hydrochloride Ethambutol Hydrochloride Versapharm Incorporated ANDA Current 61748-014 Ethambutol Hydrochloride Ethambutol Hydrochloride VersaPharm Inc. - An Akorn Company ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30755 ORIG 1999-11-30