Application 065275

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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	TE codes	Approval date
A065275-001	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14
A065275-002	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14
A065275-003	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065275-001	AP
A065275-002	AP
A065275-003	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 · 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	A065275-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065275-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065275-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065275-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065275-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065275-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-001	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-002	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-003	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2006-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065275-001	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2006-12-14	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065275-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065275-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065275-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065275-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065275-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065275-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065275-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065275-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065275-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065275-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065275-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065275-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065275-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065275-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065275-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065275-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065275-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065275-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065275-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065275-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065275-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065275-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065275-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065275-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065275-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065275-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065275-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065275-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065275-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065275-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065275-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065275-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065275-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065275-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065275-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065275-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065275-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065275-001	AP	1	`a67488948f0b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	7c20b574-285b-49eb-a98e-6752e4bb481d	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065275 application number: ANDA065275 ndc (product): 0143-9307 ndc (product): 0143-9308 ndc (product): 0143-9306
Idarubicin Hydrochloride	IDARUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b9b337d5-50f7-4ea9-9df4-72c86e4c0b91	2023-04-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065275 application number: ANDA065275 ndc (product): 0143-9219 ndc (product): 0143-9218 ndc (product): 0143-9217

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9217	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9217	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9218	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9218	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9219	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9219	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9306	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9306	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9307	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9307	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9308	Idarubicin Hydrochloride	Idarubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9308	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current