Application 021455

Type: NDA
Sponsor: HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BONIVA	IBANDRONATE SODIUM	TABLET;ORAL	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	BONIVA	IBANDRONATE SODIUM	TABLET;ORAL	EQ 150MG BASE	Yes	Yes

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

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
N021455-001	BONIVA	IBANDRONATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16
N021455-002	BONIVA	IBANDRONATE SODIUM	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	2003-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL	AB	RLD, RS	2005-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021455-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021455-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021455-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021455-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021455-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021455-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021455-002	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	7192938	2023-05-06	U-798		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	7410957	2023-05-06	U-887		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	7718634	2023-05-06	U-642		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7192938	2023-05-06	U-798		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7410957	2023-05-06	U-887		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7718634	2023-05-06	U-642		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7192938	2023-05-06	U-798		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7410957	2023-05-06	U-887		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7718634	2023-05-06	U-642		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021455-001	6294196	2019-10-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	6294196	2019-10-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7192938	2023-05-06	U-798		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7410957	2023-05-06	U-887		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7718634	2023-05-06	U-642		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7192938	2023-05-06	U-798		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7410957	2023-05-06	U-887		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7718634	2023-05-06	U-642		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7192938	2023-05-06	U-798		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7410957	2023-05-06	U-887		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7718634	2023-05-06	U-642		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7192938	2023-05-06	U-798		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7410957	2023-05-06	U-887		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7718634	2023-05-06	U-642		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7192938	2023-05-06	U-798		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7410957	2023-05-06	U-887		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7718634	2023-05-06	U-642		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7192938	2023-05-06	U-798		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7410957	2023-05-06	U-887		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7718634	2023-05-06	U-642		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7192938	2023-05-06	U-798		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7410957	2023-05-06	U-887		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7718634	2023-05-06	U-642		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021455-001	6294196	2019-10-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	6294196	2019-10-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7192938	2023-05-06	U-798		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7410957	2023-05-06	U-887		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7718634	2023-05-06	U-642		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021455-001	6294196	2019-10-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021455-002	6294196	2019-10-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021455-002	7192938	2023-05-06	U-798		`b00525d2431f…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibandronate Sodium	IBANDRONATE SODIUM	Aurobindo Pharma Limited	86c0b4ae-5e38-4efe-88af-50ac560e294f	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUM	IBANDRONATE SODIUM	Sun Pharmaceutical Industries, Inc.	be514be6-727a-4d6c-993b-52144f8e6de8	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUM	IBANDRONATE SODIUM	Golden State Medical Supply, Inc.	618e1aff-ccbb-4cee-93f1-fe04e33dacb7	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
Ibandronate sodium	IBANDRONATE SODIUM	Dr. Reddy's Laboratories Limited	f94d9c49-245a-8081-42c4-785113fce498	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
Ibandronate Sodium	IBANDRONATE SODIUM	Eugia US LLC	e81f2c5b-bead-48ac-be3e-016cf963d7ed	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUM	IBANDRONATE SODIUM	Macleods Pharmaceuticals Limited	a5741ef6-0599-4657-8cda-2902ded4f680	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
Ibandronate Sodium	IBANDRONATE SODIUM	Apotex Corp.	9fad4982-95af-d711-f50a-867311835143	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
Ibandronate sodium	IBANDRONATE SODIUM	A-S Medication Solutions	e5b6c2a9-a55f-41f9-a592-e26ef03e2d73	2025-09-22	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUM	IBANDRONATE SODIUM	Bionpharma Inc.	6ca94cce-a2bb-421f-bd8f-6b14bc2bd985	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: IBANDRONATE SODIUM

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
0004-0186	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0186	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0186	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0186	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46098	SUPPL	2016-12-08
46097	SUPPL	2016-12-08
46095	SUPPL	2016-12-07
5441	SUPPL	2015-04-13
36983	SUPPL	2015-04-10
15523	SUPPL	2015-03-24
27846	SUPPL	2015-03-19
42177	SUPPL	2015-03-11
36982	SUPPL	2014-12-19
27845	SUPPL	2014-12-18
27844	SUPPL	2013-04-24
5440	SUPPL	2013-04-24
36981	SUPPL	2013-04-23
15522	SUPPL	2013-04-23
27843	SUPPL	2011-07-06
27842	SUPPL	2011-02-02
15521	SUPPL	2011-01-31
5439	SUPPL	2010-01-15
15520	SUPPL	2010-01-08
27841	SUPPL	2008-11-28
27840	SUPPL	2007-02-23
15519	SUPPL	2007-02-21
5438	SUPPL	2006-06-20
5437	SUPPL	2005-03-28
23072	SUPPL	2005-03-25
15518	SUPPL	2005-03-25
44125	ORIG	2003-12-09
42176	ORIG	2003-07-02
5436	ORIG	2003-06-08
15517	ORIG	2003-05-29