Home Applications 065036 Application 065036
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IDARUBICIN HYDROCHLORIDE PFS IDARUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML No No 002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) No No 003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE SOLUTION;INTRAVENOUS 20MG/20ML (1MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A065036-001 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 A065036-002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 A065036-003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01
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 · 50 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 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-4154 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4154 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4154 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4154 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4154 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4155 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4155 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4155 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4155 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4155 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4156 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4156 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4156 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4156 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current 0703-4156 Idarubicin Hydrochloride Idarubicin Hydrochloride Teva Parenteral Medicines, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8377 ORIG 2003-04-09