Home Applications 022393 Application 022393
Type NDA
Sponsor CELGENE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISTODAX ROMIDEPSIN POWDER;INTRAVENOUS 10MG/VIAL 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 N022393-001 ISTODAX ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022393-001 AP
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 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022393-001 7608280 2021-08-22 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022393-001 7611724 2021-08-22 Drug substance 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N022393-001 7608280 2021-08-22 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022393-001 7611724 2021-08-22 Drug substance 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 7608280 2021-08-22 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 7611724 2021-08-22 Drug substance 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022393-001 7608280 2021-08-22 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022393-001 7611724 2021-08-22 Drug substance 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022393-001 7608280 2021-08-22 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022393-001 7611724 2021-08-22 Drug substance 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022393-001 7608280 2021-08-22 Drug substance c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022393-001 7611724 2021-08-22 Drug substance c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022393-001 7608280 2021-08-22 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022393-001 7611724 2021-08-22 Drug substance 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022393-001 7608280 2021-08-22 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022393-001 7611724 2021-08-22 Drug substance b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022393-001 7608280 2021-08-22 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022393-001 7611724 2021-08-22 Drug substance ea99ee380514…
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0983 Romidepsin romidepsin PFIZER LABORATORIES DIV PFIZER INC NDA AUTHORIZED GENERIC Current 0069-0983 Romidepsin romidepsin PFIZER LABORATORIES DIV PFIZER INC NDA AUTHORIZED GENERIC Current 0703-3125 Romidepsin romidepsin Teva Parenteral Medicines, Inc. NDA AUTHORIZED GENERIC Current 0703-3125 Romidepsin romidepsin Teva Parenteral Medicines, Inc. NDA AUTHORIZED GENERIC Current 0703-3125 Romidepsin romidepsin Teva Parenteral Medicines, Inc. NDA AUTHORIZED GENERIC Current 0703-3125 Romidepsin romidepsin Teva Parenteral Medicines, Inc. NDA AUTHORIZED GENERIC Current 0703-3125 Romidepsin romidepsin Teva Parenteral Medicines, Inc. NDA AUTHORIZED GENERIC Current 59572-984 ISTODAX romidepsin Celgene Corporation NDA Current 59572-984 ISTODAX romidepsin Celgene Corporation NDA Current 59572-984 ISTODAX romidepsin Celgene Corporation NDA Current