Home Applications 022561 Application 022561
Type NDA
Sponsor EMD SERONO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MAVENCLAD CLADRIBINE TABLET;ORAL 10MG 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 N022561-001 MAVENCLAD CLADRIBINE 10MG TABLET / ORAL AB RLD, RS 2019-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022561-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022561-001 10849919 2038-11-23 U-3411 2022-09-09 N022561-001 12533408 2041-09-10 U-4395 2026-01-27 N022561-001 12539329 2041-09-10 U-4399 2026-02-03
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 N022561-001 MAVENCLAD 10MG TABLET / ORAL AB RLD, RS 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL AB RLD, RS 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022561-001 MAVENCLAD 10MG TABLET / ORAL RLD, RS 2019-03-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022561-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022561-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022561-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 180 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 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022561-001 12533408 2041-09-10 U-4395 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022561-001 12539329 2041-09-10 U-4399 2026-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 7888328 2024-04-11 U-2521 Drug product 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 8785415 2024-04-11 U-2523 Drug product 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 7888328 2024-04-11 U-2521 Drug product 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 8785415 2024-04-11 U-2523 Drug product 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 7888328 2024-04-11 U-2521 Drug product 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 8785415 2024-04-11 U-2523 Drug product 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 7888328 2024-04-11 U-2521 Drug product 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 8785415 2024-04-11 U-2523 Drug product 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 7713947 2026-10-16 U-2520 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022561-001 10849919 2038-11-23 U-3411 2022-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022561-001 7888328 2024-04-11 U-2521 Drug product 2019-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022561-001 8785415 2024-04-11 U-2523 Drug product 2019-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022561-001 8377903 2026-05-31 U-2522 2019-05-28 d06236e962d9…
Observed Orange Book exclusivity history# 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44087-4000 Mavenclad Cladribine EMD Serono, Inc. NDA Current 44087-4000 Mavenclad Cladribine EMD Serono, Inc. NDA Current 44087-4000 Mavenclad Cladribine EMD Serono, Inc. NDA Current