Home Applications 018332 Application 018332
Type NDA
Sponsor EGALET Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INDOCIN INDOMETHACIN SUSPENSION;ORAL 25MG/5ML 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 N018332-001 INDOCIN INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018332-001 AB
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 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 cb3db0bc1861…
Observed Orange Book normalized TE 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Indocin INDOMETHACIN Zyla Life Sciences US LLC 73878376-1d24-423b-9f37-3666e83c95da 2024-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018332 application number: NDA018332 ndc (product): 69344-101
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42211-101 INDOCIN indomethacin Iroko Pharmaceuticals, LLC NDA Current 69344-101 Indocin indomethacin Egalet US Inc. NDA Current 69344-101 Indocin indomethacin Zyla Life Sciences US Inc. NDA Current 69344-101 Indocin indomethacin Zyla Life Sciences US Inc. NDA Current