Home Applications 208800 Application 208800
Type ANDA
Sponsor TARO PHARM INDS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEFERIPRONE DEFERIPRONE TABLET;ORAL 500MG No No 002 DEFERIPRONE DEFERIPRONE TABLET;ORAL 1GM No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A208800-001 DEFERIPRONE DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 A208800-002 DEFERIPRONE DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22
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 2 · 61 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 2026-08-18 06:07:40 2026-07 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL 2019-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A208800-001 PC 2021-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208800-001 PC 2021-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208800-001 PC 2021-03-27 5aa47cf7b7d7…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51672-4196 Deferiprone Deferiprone Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4196 Deferiprone Deferiprone Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4196 Deferiprone Deferiprone Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4196 Deferiprone Deferiprone Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4196 Deferiprone Deferiprone Taro Pharmaceuticals U.S.A., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 50739 ORIG 2019-03-12