Application 065440

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IDARUBICIN HYDROCHLORIDE	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	Approval date
A065440-001	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	2009-08-04
A065440-002	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	2009-08-04
A065440-003	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	2009-08-04

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065440-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065440-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065440-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065440-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065440-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065440-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065440-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065440-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065440-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2009-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2009-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065440-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2009-08-04	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065440-001	AP	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A065440-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065440-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065440-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065440-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065440-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065440-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065440-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065440-001	AP	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Idamycin PFS	IDARUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	0a5a6d93-cc1e-4d7f-8da1-446c134503b3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	d31254be-6bd2-4ac1-acab-bc00e2209d28	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Idarubicin Hydrochloride generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	7c20b574-285b-49eb-a98e-6752e4bb481d	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Idarubicin Hydrochloride generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b9b337d5-50f7-4ea9-9df4-72c86e4c0b91	2023-04-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Idarubicin Hydrochloride generic name: IDARUBICIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-194	Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current