Application 062921

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/VIAL	No	Yes
002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/VIAL	No	Yes
003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/VIAL	No	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
A062921-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17
A062921-002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17
A062921-003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062921-002	AP
A062921-003	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 4 · 123 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	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062921-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062921-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062921-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062921-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062921-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062921-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062921-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062921-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062921-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062921-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062921-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062921-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062921-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062921-003	AP	1	`74a2ff9319b5…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	f62aa88d-1e25-4049-87ec-99d42edd1d31	2024-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062921 application number: ANDA062921 ndc (product): 0143-9093 ndc (product): 0143-9092

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9092	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9092	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9093	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9093	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9275	Adriamycin	Doxorubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9275	Adriamycin	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9275	Adriamycin	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9277	Adriamycin	Doxorubicin Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9277	Adriamycin	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9277	Adriamycin	Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18313	SUPPL	2012-12-12