Application 021602

Type: NDA
Sponsor: MILLENNIUM PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VELCADE	BORTEZOMIB	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	3.5MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021602-001	VELCADE	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021602-001	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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021602-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021602-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021602-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021602-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021602-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021602-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021602-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021602-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021602-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021602-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021602-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021602-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021602-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021602-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021602-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021602-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021602-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021602-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021602-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021602-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021602-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021602-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021602-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021602-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021602-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021602-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021602-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021602-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021602-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021602-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	PED	2022-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021602-001	PED	2022-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021602-001	PED	2022-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021602-001	PED	2019-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	ODE-76	2021-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	PED	2022-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021602-001	PED	2022-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021602-001	ODE-76	2021-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	PED	2022-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	ODE-76	2021-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	PED	2022-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021602-001	ODE-76	2021-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	PED	2022-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021602-001	ODE-76	2021-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	PED	2022-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021602-001	ODE-76	2021-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	PED	2022-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021602-001	PED	2019-03-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021602-001	ODE-76	2021-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021602-001	PED	2022-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021602-001	PED	2019-03-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021602-001	ODE-76	2021-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021602-001	PED	2022-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021602-001	PED	2019-03-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021602-001	ODE-76	2021-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021602-001	PED	2022-04-08	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021602-001	PED	2022-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021602-001	PED	2022-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021602-001	PED	2022-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	PED	2022-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021602-001	PED	2022-04-08	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VELCADE	BORTEZOMIB	Takeda Pharmaceuticals America, Inc.	1521d321-e724-4ffc-adad-34bf4f44fac7	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021602 application number: NDA021602 ndc (product): 63020-049

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-049	VELCADE	bortezomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-049	VELCADE	bortezomib	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69260	SUPPL	2021-11-05
69254	SUPPL	2021-11-05
69127	SUPPL	2021-10-26
69116	SUPPL	2021-10-26
58444	SUPPL	2019-04-26
58430	SUPPL	2019-04-26
50607	SUPPL	2017-12-06
48702	SUPPL	2017-06-12
48694	SUPPL	2017-06-12
37326	SUPPL	2015-09-23
28234	SUPPL	2015-09-16
37325	SUPPL	2014-10-09
28233	SUPPL	2014-10-09
15860	SUPPL	2014-08-12
5831	SUPPL	2014-08-12
51265	SUPPL	2012-11-13
28232	SUPPL	2012-10-29
5830	SUPPL	2012-10-29
37324	SUPPL	2012-10-26
15859	SUPPL	2012-10-26
28230	SUPPL	2012-01-25
37322	SUPPL	2012-01-23
37323	SUPPL	2011-11-04
15858	SUPPL	2011-11-04
28231	SUPPL	2011-11-03
5829	SUPPL	2011-11-03
21755	SUPPL	2011-10-10
51264	SUPPL	2011-01-26
21754	SUPPL	2011-01-07
28229	SUPPL	2010-12-07
15857	SUPPL	2010-12-04
51263	SUPPL	2010-04-27
37321	SUPPL	2010-01-12
37320	SUPPL	2010-01-12
28228	SUPPL	2010-01-05
5828	SUPPL	2010-01-05
5827	SUPPL	2009-05-04
5826	SUPPL	2008-06-24
37319	SUPPL	2008-06-23
5825	SUPPL	2007-10-15
15856	SUPPL	2007-10-10
5824	SUPPL	2006-12-28
15855	SUPPL	2006-12-08
28227	SUPPL	2006-06-02
37318	SUPPL	2006-06-01
28226	SUPPL	2005-12-15
5823	SUPPL	2005-03-30
37317	SUPPL	2005-03-25
5822	SUPPL	2004-06-01
44137	ORIG	2003-12-12
42229	ORIG	2003-09-25
5821	ORIG	2003-05-16
37316	ORIG	2003-05-13
52043	SUPPL	1900-01-01
52042	SUPPL	1900-01-01
52040	SUPPL	1900-01-01