Application 210824

Type: ANDA
Sponsor: QILU PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BORTEZOMIB	BORTEZOMIB	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	3.5MG/VIAL	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210824-001	BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP		2022-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210824-001	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.

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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210824-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210824-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210824-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210824-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210824-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210824-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210824-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210824-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210824-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210824-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210824-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210824-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210824-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210824-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210824-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210824-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210824-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210824-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210824-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210824-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210824-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210824-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210824-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210824-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210824-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210824-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210824-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210824-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210824-001	AP	1	`a50c72e98297…`

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
BORTEZOMIB	BORTEZOMIB	Sagent Pharmaceuticals	945fbaf0-7a79-4676-aa90-e9a213c0654f	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824
Bortezomib	BORTEZOMIB	BluePoint Laboratories	12500f21-8e2f-4bcd-861e-4dfca843da2e	2022-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824 ndc (product): 68001-540
Bortezomib	BORTEZOMIB	Qilu Pharmaceutical Co., Ltd.	aef02171-bf8a-43ad-b40c-7642623f9802	2022-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824 ndc (product): 67184-0530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-484	Bortezomib	Bortezomib	Ingenus Pharmaceuticals, LLC	ANDA	Current
67184-0530	Bortezomib	Bortezomib	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
68001-540	Bortezomib	Bortezomib	BluePoint Laboratories	ANDA	Current
70860-225	Bortezomib	bortezomib	Athenex Pharmaceutical Division, LLC.	ANDA	Current