Home Applications 018829 Application 018829
Type NDA
Sponsor CHARTWELL MOLECULES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INDOMETHACIN INDOMETHACIN CAPSULE;ORAL 50MG No No 002 INDOMETHACIN INDOMETHACIN CAPSULE;ORAL 25MG 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 N018829-001 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 N018829-002 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06
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 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62135-067 INDOMETHACIN INDOMETHACIN Chartwell RX, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80372 SUPPL 2024-11-25 80371 SUPPL 2024-11-25 80277 SUPPL 2024-11-22 67302 SUPPL 2021-04-30 67301 SUPPL 2021-04-30 67258 SUPPL 2021-04-29 33620 SUPPL 2016-05-11 16065 SUPPL 2016-05-11