Application 206927

Type: NDA
Sponsor: DR REDDYS LABS LTD

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 43.

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
N206927-001	BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS			2019-10-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206927-001	BORTEZOMIB	3.5MG/VIAL	POWDER / INTRAVENOUS	2019-10-04	`cb3db0bc1861…`

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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bortezomib	BORTEZOMIB	Sintetica US LLC	d79a71ec-b46d-4961-ad05-8980915cba94	2023-10-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Hospira, Inc.	9fdf6169-699f-40eb-bda1-760253062b3c	2023-02-27	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Novadoz Pharmaceuticals LLC	d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e	2022-07-20	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	BluePoint Laboratories	12500f21-8e2f-4bcd-861e-4dfca843da2e	2022-05-16	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Qilu Pharmaceutical Co., Ltd.	aef02171-bf8a-43ad-b40c-7642623f9802	2022-05-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Zydus Lifesciences Limited	582c7c0d-fa25-4586-8157-a1e2653d72d9	2022-05-05		Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Pharmascience Inc.	191d231a-1fbd-4a65-9d33-d5dc03bac381	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Waverley Pharma Inc	a73d7ea7-d068-4d25-b368-fc3db1898be2	2022-04-13	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
bortezomib	BORTEZOMIB	Hikma Pharmaceuticals USA Inc.	854be921-5fd9-482a-8432-a0c0241625f8	2021-11-22	Warnings, Adverse reactions	Name fallback brand name: bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	MAIA Pharmaceuticals, Inc.	c40e6a28-d577-43d4-bca6-bef28da1d580	2021-09-22	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-865	Bortezomib	Bortexomib	Dr.Reddy's Laboratories Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70360	SUPPL	2022-03-02
70310	SUPPL	2022-03-01
61941	ORIG	2020-02-21
60258	ORIG	2019-10-07
60248	ORIG	2019-10-07