Home Applications 210166 Application 210166
Type NDA
Sponsor SHIRE DEV LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MOTEGRITY PRUCALOPRIDE SUCCINATE TABLET;ORAL EQ 1MG BASE Yes No 002 MOTEGRITY PRUCALOPRIDE SUCCINATE TABLET;ORAL EQ 2MG BASE Yes Yes
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 N210166-001 MOTEGRITY PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 N210166-002 MOTEGRITY PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210166-001 M-14 2028-07-10 N210166-002 M-14 2028-07-10
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 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54092-546 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Shire US Manufacturing Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-546 MOTEGRITY PRUCALOPRIDE Shire US Manufacturing Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Shire US Manufacturing Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Takeda Pharmaceuticals America, Inc. NDA Current 54092-547 MOTEGRITY PRUCALOPRIDE Shire US Manufacturing Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82816 SUPPL 2025-07-11 82786 SUPPL 2025-07-11 65195 SUPPL 2020-11-12 65181 SUPPL 2020-11-10 57043 ORIG 2018-12-28 56890 ORIG 2018-12-20 56744 ORIG 2018-12-14