Home Applications 021775 Application 021775
Type NDA
Sponsor CUBIST PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENTEREG ALVIMOPAN CAPSULE;ORAL 12MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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Approval date N021775-001 ENTEREG ALVIMOPAN 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20
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 N021775-001 8946262 2030-02-12 U-1655 2015-02-19
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 · 43 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 2026-09-14 22:38:34 2026-08 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021775-001 ENTEREG 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2008-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD, RS 2008-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD, RS 2008-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD, RS 2008-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD, RS 2008-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD, RS 2008-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021775-001 ENTEREG 12MG CAPSULE / ORAL RLD 2008-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021775-001 ENTEREG 12MG CAPSULE / ORAL AB RLD, RS 2008-05-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 61 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021775-001 6469030 2020-11-29 U-879 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021775-001 8645160 2029-06-18 U-1485 Delist requested 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021775-001 8112290 2030-07-31 U-1443 Delist requested 2012-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021775-001 6469030 2020-11-29 U-879 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021775-001 8645160 2029-06-18 U-1485 Delist requested 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021775-001 8112290 2030-07-31 U-1443 Delist requested 2012-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021775-001 6469030 2020-11-29 U-879 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021775-001 8645160 2029-06-18 U-1485 Delist requested c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021775-001 8112290 2030-07-31 U-1443 Delist requested 2012-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021775-001 6469030 2020-11-29 U-879 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021775-001 8645160 2029-06-18 U-1485 Delist requested 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021775-001 8946262 2030-02-12 U-1655 2015-02-19 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021775-001 8112290 2030-07-31 U-1443 Delist requested 2012-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021775-001 6469030 2020-11-29 U-879 b00525d2431f…
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alvimopan ALVIMOPAN Golden State Medical Supply, Inc. 10e39d3b-8621-16f8-e063-6294a90a254e 2024-02-08 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ALVIMOPAN ALVIMOPAN ALVIMOPAN Par Health USA, LLC 1cd584de-b704-4d26-8451-e3247ffb8d08 2024-02-02 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ALVIMOPAN Alvimopan ALVIMOPAN Hikma Pharmaceuticals USA Inc. 59ef406b-79db-4efd-b993-08b937ac682b 2022-10-24 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ALVIMOPAN Alvimopan ALVIMOPAN Actavis Pharma, Inc. 2a0645b4-daf8-421f-b987-a4e478843c5d 2021-01-31 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ALVIMOPAN
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67919-020 Entereg alvimopan Merck Sharp & Dohme Corp. NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme Corp. NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme LLC NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme LLC NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme Corp. NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme Corp. NDA Current 67919-020 Entereg alvimopan Merck Sharp & Dohme Corp. NDA Current