Home Applications 208587 Application 208587
Type NDA
Sponsor EMMAUS MEDCL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENDARI L-GLUTAMINE FOR SOLUTION;ORAL 5GM/PACKET Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N208587-001 ENDARI L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208587-001 AA
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 · 42 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 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 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 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current 42457-420 Endari Glutamine Emmaus Medical, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82617 SUPPL 2025-06-20 82608 SUPPL 2025-06-20 65118 SUPPL 2020-11-02 65083 SUPPL 2020-10-30 62654 SUPPL 2020-04-23 62647 SUPPL 2020-04-23 60786 SUPPL 2019-11-06 60783 SUPPL 2019-11-05 53646 ORIG 2018-04-10 48945 ORIG 2017-07-11 48926 ORIG 2017-07-07