Home Applications 207865 Application 207865
Type NDA
Sponsor MSD MERCK CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMEND APREPITANT FOR SUSPENSION;ORAL 125MG/KIT 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 N207865-001 EMEND APREPITANT 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18
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 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207865-001 EMEND 125MG/KIT FOR SUSPENSION / ORAL RLD, RS 2015-12-17 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207865-001 8258132 2027-09-26 U-1916 Drug product 2016-11-18 cb3db0bc1861…
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3066 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current