Home Applications 050734 Application 050734
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML Yes Yes 002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) Yes Yes 003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE SOLUTION;INTRAVENOUS 20MG/20ML (1MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050734-001 IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 N050734-002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 N050734-003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 47 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 N050734-001 IDAMYCIN PFS 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050734-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050734-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050734-001 IDAMYCIN PFS 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050734-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050734-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050734-001 IDAMYCIN PFS 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1997-02-17 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0013-2576 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2576 Idamycin PFS idarubicin hydrochloride Pharmacia & Upjohn Company LLC NDA Current 0013-2576 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2576 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current 0013-2576 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2576 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pharmacia & Upjohn Company LLC NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2586 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pharmacia & Upjohn Company LLC NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0013-2596 Idamycin PFS idarubicin hydrochloride Pfizer Laboratories Div Pfizer Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84965 SUPPL 2026-02-06 84963 SUPPL 2026-02-06 76870 SUPPL 2023-12-15 76852 SUPPL 2023-12-15 70863 SUPPL 2022-04-29 70839 SUPPL 2022-04-27 66248 SUPPL 2021-02-17 66194 SUPPL 2021-02-11 59575 SUPPL 2019-08-05 59573 SUPPL 2019-08-05 39217 SUPPL 2015-01-09 8146 SUPPL 2014-12-05 8145 SUPPL 2003-05-30 18144 SUPPL 2003-05-06