Home Applications 212862 Application 212862
Type NDA
Sponsor MYLAN IRELAND LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRETOMANID PRETOMANID TABLET;ORAL 200MG 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 N212862-001 PRETOMANID PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212862-001 NCE 2024-08-14 N212862-001 ODE-253 2026-08-14 N212862-001 GAIN 2029-08-14
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.
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 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 119 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49502-476 Pretomanid Pretomanid Mylan Specialty L.P. NDA Current 49502-476 Pretomanid Pretomanid Mylan Specialty L.P. NDA Current 49502-476 Pretomanid Pretomanid Mylan Specialty L.P. NDA Current 49502-476 Pretomanid Pretomanid Mylan Specialty L.P. NDA Current 49502-476 Pretomanid Pretomanid Mylan Specialty LP NDA Current 49502-476 Pretomanid Pretomanid Mylan Specialty L.P. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80424 SUPPL 2024-11-26 80355 SUPPL 2024-11-25 80354 SUPPL 2024-11-25 73007 SUPPL 2022-12-22 73006 SUPPL 2022-12-22 73000 SUPPL 2022-12-22 59986 ORIG 2019-09-12 59738 ORIG 2019-08-16 59702 ORIG 2019-08-14 59701 ORIG 2019-08-14