Home Applications 210238 Application 210238
Type NDA
Sponsor AKARX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOPTELET AVATROMBOPAG MALEATE TABLET;ORAL EQ 20MG BASE 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 N210238-001 DOPTELET AVATROMBOPAG MALEATE EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21
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 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210238-001 ODE-246 2026-06-26 N210238-001 I-974 2028-07-24 N210238-001 ODE-548 2032-07-24
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 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 113 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 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 91 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current 71369-020 DOPTELET avatrombopag maleate AkaRx, Inc. NDA Current