Application 205004

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N205004-001	BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS			2017-11-06

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205004-001	8962572	2032-11-03		Drug product	2017-11-21

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205004-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2017-11-06	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205004-001	8962572	2032-11-03	Drug product	2017-11-21	`e64feba35796…`

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bortezomib	BORTEZOMIB	Avenacy, LLC	decb5d94-2ea2-48d8-b08b-3196b24c0ed3	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Gland Pharma Limited	cd698074-da21-4b53-8f6b-241535a8d598	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Ningbo Shuangcheng Pharmaceutical Co., Ltd.	b17ca681-59a5-4af7-98a4-953b38379893	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Eugia US LLC	ed526447-a4fe-403b-8f08-21ce1b2fa8b7	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	BluePoint Laboratories	10f60367-0476-4acd-861b-90c18d4b8164	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Apotex Corp	b605b541-4bfd-db3e-9710-11c27f6dee6c	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
VELCADE	BORTEZOMIB	Takeda Pharmaceuticals America, Inc.	1521d321-e724-4ffc-adad-34bf4f44fac7	2025-08-28	Warnings, Adverse reactions	Name fallback generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	BluePoint Laboratories	c6b620c6-f3d6-4ff3-b46a-50a66e6d41dd	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Meitheal Pharmaceuticals Inc.	322e315f-dd94-475f-94f4-4d86a7eb5590	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORUZU	BORTEZOMIB	Amneal Pharmaceuticals LLC	b92628dd-fa09-4c3a-b6a3-66426025807c	2025-07-05	Warnings, Adverse reactions	Name fallback generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Somerset Therapeutics LLC	dc737d3d-2a4e-448a-ad70-e013065c411c	2025-05-10	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	NorthStar RxLLC	3f02670b-5683-780c-9d38-5d8f0ef43a14	2025-05-06	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Sagent Pharmaceuticals	945fbaf0-7a79-4676-aa90-e9a213c0654f	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Fresenius Kabi USA, LLC	3494c357-a692-4e55-89e1-93532b0baef7	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Zydus Pharmaceuticals USA Inc.	0eb8daef-18da-43bb-b7c6-38c4c8b5dd80	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Shilpa Medicare Limited	61539d49-dc21-4576-8813-4bc8abf3868c	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Camber Pharmaceuticals, Inc.	04aafa6a-a50d-4a47-a831-be8e8bb992ac	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Dr.Reddy's Laboratories, Inc.	664bee24-7af2-2099-ac99-5dd71a1e5a14	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Hospira, Inc.	41e3de39-8278-4a75-badf-601e4602080d	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Eugia US LLC	76c7c3a5-fd2f-403f-85fd-65a64538eee7	2023-10-20	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB

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
63323-721	Bortezomib	Bortezomib	Fresenius Kabi USA, LLC	NDA	Current
63323-721	Bortezomib	Bortezomib	Fresenius Kabi USA, LLC	NDA	Current
63323-721	Bortezomib	Bortezomib	Fresenius Kabi USA, LLC	NDA	Current
63323-721	Bortezomib	Bortezomib	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68720	SUPPL	2021-09-22
68685	SUPPL	2021-09-21
57403	SUPPL	2019-02-01
54895	SUPPL	2018-07-16
54877	SUPPL	2018-07-13
50696	ORIG	2017-12-14
50454	ORIG	2017-11-17
50320	ORIG	2017-11-07