Application 212299

Type: ANDA
Sponsor: ZYDUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE, LIPOSOMAL;INJECTION	20MG/10ML (2MG/ML)	No	No
002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE, LIPOSOMAL;INJECTION	50MG/25ML (2MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2020-09-10
A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2020-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212299-001	AB
A212299-002	AB

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 · 74 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
2026-02-19 14:30 UTC	2026-02	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212299-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212299-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212299-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212299-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2020-09-10	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A212299-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212299-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212299-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212299-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212299-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212299-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212299-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212299-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212299-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212299-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212299-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212299-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212299-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212299-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212299-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212299-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212299-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212299-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212299-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212299-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212299-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212299-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212299-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212299-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212299-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212299-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212299-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212299-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212299-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212299-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212299-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212299-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212299-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212299-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212299-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212299-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212299-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212299-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212299-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212299-002	AB	1	`87673890dc5c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	ada390ce-50ea-4de5-be58-5b03caf33c23	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212299 application number: ANDA212299
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	15a84bd6-b565-4722-bb92-e4c919620a90	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212299 application number: ANDA212299 ndc (product): 70710-1530 ndc (product): 70710-1531
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	Zydus Lifesciences Limited	bad467d4-7e27-4eda-b4d3-854460f0adab	2022-11-01		Exact identifier application applno (ANDA): 212299 application number: ANDA212299 ndc (product): 49315-009 ndc (product): 49315-008

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49315-008	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Lifesciences Limited	ANDA	Current
49315-008	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Cadila Healthcare Limited	ANDA	Current
49315-009	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Lifesciences Limited	ANDA	Current
49315-009	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Cadila Healthcare Limited	ANDA	Current
70710-1530	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1530	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1531	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1531	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current