Home Applications 022405 Application 022405
Type NDA
Sponsor GENZYME CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAPRELSA VANDETANIB TABLET;ORAL 100MG Yes No 002 CAPRELSA VANDETANIB TABLET;ORAL 300MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022405-001 CAPRELSA VANDETANIB 100MG TABLET / ORAL RLD 2011-04-06 N022405-002 CAPRELSA VANDETANIB 300MG TABLET / ORAL RLD, RS 2011-04-06
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022405-001 8067427 2028-08-08 Drug product 2011-12-21 N022405-002 8067427 2028-08-08 Drug product
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 · 84 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 2026-08-18 06:07:40 2026-07 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 5 · 174 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022405-002 8067427 2028-08-08 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022405-002 8067427 2028-08-08 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-002 8067427 2028-08-08 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022405-002 8067427 2028-08-08 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-002 8067427 2028-08-08 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-002 8067427 2028-08-08 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-002 8067427 2028-08-08 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-002 8067427 2028-08-08 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-002 8067427 2028-08-08 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-002 8067427 2028-08-08 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022405-002 8067427 2028-08-08 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-002 8067427 2028-08-08 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-002 8067427 2028-08-08 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-002 8067427 2028-08-08 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022405-002 8067427 2028-08-08 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 8642608 2022-02-06 U-1490 2018-03-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 8642608 2022-02-06 U-1490 2018-03-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 8067427 2028-08-08 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022405-001 8642608 2022-02-06 U-1490 2018-03-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-001 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-002 8642608 2022-02-06 U-1490 2018-03-05 5d02ea3f76ae…
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 0310-7820 CAPRELSA Vandetanib AstraZeneca Pharmaceuticals LP NDA Current 0310-7840 CAPRELSA Vandetanib AstraZeneca Pharmaceuticals LP NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7820 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current 58468-7840 CAPRELSA Vandetanib Genzyme Corporation NDA Current