Application 207228

Type: ANDA
Sponsor: AYANA PHARMA LTD

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 44.

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
A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2021-10-12
A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2021-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207228-001	AB
A207228-002	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 · 72 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
2026-10-15 13:18:30	2026-09	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207228-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207228-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207228-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207228-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207228-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207228-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207228-001	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207228-002	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-10-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207228-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207228-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207228-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207228-002	AB	1	`4b0b4de00fa7…`

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 2 of 2 · 28 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	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	36924f82-6c05-4989-9f41-a398c0ad48e6	2024-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	971de64b-ff09-4370-afd9-6eb1093ad27d	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride, Liposomal	DOXORUBICIN HYDROCHLORIDE	Baxter Healthcare Corporation	b24afa8c-636b-4ace-99d5-51f445ad3123	2023-12-19		Name fallback generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	Zydus Lifesciences Limited	bad467d4-7e27-4eda-b4d3-854460f0adab	2022-11-01		Name fallback brand name: DOXORUBICIN HYDROCHLORIDE generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Mylan Institutional LLC	5f71f79a-4f14-472d-b982-e28c3ce8f972	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
DOXIL	DOXORUBICIN HYDROCHLORIDE	Baxter Healthcare Company	1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce	2022-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DOXORUBICIN HYDROCHLORIDE
DOXOrubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	6bcde92b-e584-4919-866a-68847ea201ba	2022-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXOrubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

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
0574-0930	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
0574-0930	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
0574-0930	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
0574-0931	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
0574-0931	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
0574-0931	doxorubicin hydrochloride	doxorubicin hydrochloride	Padagis US LLC	ANDA	Current
63629-9530	doxorubicin hydrochloride	doxorubicin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9531	doxorubicin hydrochloride	doxorubicin hydrochloride	Bryant Ranch Prepack	ANDA	Current