Home Applications 206505 Application 206505
Type ANDA
Sponsor NOVITIUM PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAPSONE DAPSONE TABLET;ORAL 25MG No No 002 DAPSONE DAPSONE TABLET;ORAL 100MG 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 A206505-001 DAPSONE DAPSONE 25MG TABLET / ORAL AB 2016-12-01 A206505-002 DAPSONE DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01
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 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0904-7018 DAPSONE Dapsone Major Pharmaceuticals ANDA Current 0904-7019 DAPSONE Dapsone Major Pharmaceuticals ANDA Current 10135-654 DAPSONE Dapsone Marlex Pharmaceuticals Inc ANDA Current 10135-655 DAPSONE Dapsone Marlex Pharmaceuticals Inc ANDA Current 70954-135 DAPSONE Dapsone ANI Pharmaceuticals, Inc. ANDA Current 70954-135 DAPSONE Dapsone Novitium Pharma LLC ANDA Current 70954-136 DAPSONE Dapsone ANI Pharmaceuticals, Inc. ANDA Current 70954-136 DAPSONE Dapsone Novitium Pharma LLC ANDA Current