Home Applications 065468 Application 065468
Type ANDA
Sponsor BRECKENRIDGE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEOMYCIN SULFATE NEOMYCIN SULFATE TABLET;ORAL 500MG 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 A065468-001 NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29
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 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2010-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2010-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2010-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2010-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065468-001 NEOMYCIN SULFATE 500MG TABLET / ORAL 2010-03-29 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 · 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neomycin Sulfate NEOMYCIN SULFATE Shaanxi Shuvita Biotech Co., Ltd 573e1fe7-4d9d-0a5f-e063-6394a90a85a8 2026-07-22 Warnings Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE Neomycin Sulfate NEOMYCIN SULFATE REMEDYREPACK INC. 461f62b9-b9ec-43f2-aee7-0895638105b8 2026-04-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE Neomycin Sulfate NEOMYCIN SULFATE Chartwell RX, LLC 0aa6947b-4739-4b00-be93-7303a5fc687d 2026-02-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE Neomycin Sulfate NEOMYCIN SULFATE Aldermed Inc. 4978bb06-8b7c-9a44-e063-6294a90ac4cf 2026-02-12 Warnings Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC NEOMYCIN SULFATE Compania Internacional de Comercio, S.A.P.I de C.V. ba7a3331-466e-496f-bebd-9ee7067bcdb2 2025-11-19 Warnings Name fallback generic name: NEOMYCIN SULFATE POMADA SULFA FIRST AID ANTIBIOTIC NEOMYCIN SULFATE GRANDALL DISTRIBUTING, LLC 1d8e1fca-6864-7c08-e063-6394a90a08b6 2025-10-28 Warnings Name fallback generic name: NEOMYCIN SULFATE Antibiotic NEOMYCIN SULFATE Total Resources International 0725364b-b243-4891-af2f-a6049366d038 2025-10-10 Warnings Name fallback generic name: NEOMYCIN SULFATE Neomycin Sulfate NEOMYCIN SULFATE Solaris Pharma Corporation f430c5d9-ae82-3314-e053-2a95a90af04c 2025-10-03 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE Pomada de Sulfa NEOMYCIN SULFATE Menper Distributors, Inc. 216f4d22-e5e8-46c8-a4ef-8d1532792b56 2025-07-22 Warnings Name fallback generic name: NEOMYCIN SULFATE First Aid Only Neomycin Antibiotic NEOMYCIN SULFATE Acme United Corporation c651e98e-aabe-de46-e053-2a95a90a6307 2024-11-19 Warnings Name fallback generic name: NEOMYCIN SULFATE Single Antibiotic with Neomycin NEOMYCIN SULFATE Safetec of America e989cf7e-f3d1-42d2-af45-fc80095b97cb 2024-02-08 Warnings Name fallback generic name: NEOMYCIN SULFATE Neomycin Sulfate NEOMYCIN SULFATE Teva Pharmaceuticals USA, Inc. 777dbfab-f83e-4738-ae1e-78619a9f82a7 2022-10-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Neomycin Sulfate generic name: NEOMYCIN SULFATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51991-738 NEOMYCIN SULFATE NEOMYCIN SULFATE Breckenridge Pharmaceutical, Inc. ANDA Current