Home Applications 022277 Application 022277
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEMODAR TEMOZOLOMIDE POWDER;INTRAVENOUS 100MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022277-001 TEMODAR TEMOZOLOMIDE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27
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 · 42 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 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 7786118 2023-02-21 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 6987108 2023-09-08 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022277-001 7786118 2023-02-21 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022277-001 6987108 2023-09-08 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022277-001 7786118 2023-02-21 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022277-001 6987108 2023-09-08 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022277-001 7786118 2023-02-21 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022277-001 6987108 2023-09-08 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022277-001 7786118 2023-02-21 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022277-001 6987108 2023-09-08 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022277-001 7786118 2023-02-21 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022277-001 6987108 2023-09-08 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 7786118 2023-02-21 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 6987108 2023-09-08 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022277-001 7786118 2023-02-21 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022277-001 6987108 2023-09-08 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022277-001 7786118 2023-02-21 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022277-001 6987108 2023-09-08 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022277-001 7786118 2023-02-21 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022277-001 6987108 2023-09-08 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022277-001 7786118 2023-02-21 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022277-001 6987108 2023-09-08 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022277-001 7786118 2023-02-21 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022277-001 6987108 2023-09-08 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022277-001 7786118 2023-02-21 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022277-001 6987108 2023-09-08 Drug product ea99ee380514…2023-12-20 04:57 UTC 2023-12 N022277-001 7786118 2023-02-21 Drug product ea1830bbd6c7…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme Corp. NDA Current 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme Corp. NDA Current 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme LLC NDA Current 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme LLC NDA Current 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme Corp. NDA Current 0085-1381 TEMODAR Temozolomide Merck Sharp & Dohme Corp. NDA Current