Application 065037

Type: ANDA
Sponsor: TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/VIAL	No	No
002	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/VIAL	No	No
003	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A065037-001	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	POWDER / INTRAVENOUS	2002-05-01
A065037-002	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	POWDER / INTRAVENOUS	2002-05-01
A065037-003	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	POWDER / INTRAVENOUS	2002-05-01

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065037-003	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065037-001	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065037-002	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	2002-05-01	`c0c555d07b60…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8378	ORIG	2003-04-09