Home Applications 019569 Application 019569
Type NDA
Sponsor MISSION PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 THIOLA TIOPRONIN TABLET;ORAL 100MG Yes Yes
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 N019569-001 THIOLA TIOPRONIN 100MG TABLET / ORAL AB RLD, RS 1988-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019569-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N019569-001 ODE-267 2026-06-28
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 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0178-0900 Thiola tiopronin Mission Pharmacal Company NDA Current 0178-0900 Thiola tiopronin Mission Pharmacal Company NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59223 SUPPL 2019-07-02 59202 SUPPL 2019-07-01