Application 021858

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BONIVA	IBANDRONATE SODIUM	INJECTABLE;INTRAVENOUS	EQ 3MG BASE/3ML	Yes	Yes

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
N021858-001	BONIVA	IBANDRONATE SODIUM	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021858-001	BONIVA	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021858-001	BONIVA	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-01-06	`e64feba35796…`

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	N021858-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021858-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021858-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021858-001	AP	1	`ea99ee380514…`

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
0004-0191	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0191	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0191	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current
0004-0191	Boniva	ibandronate sodium	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69846	SUPPL	2022-01-12
69845	SUPPL	2022-01-12
46648	SUPPL	2017-01-03
46141	SUPPL	2016-12-13
46105	SUPPL	2016-12-09
6316	SUPPL	2015-04-13
37769	SUPPL	2015-04-10
37768	SUPPL	2015-03-19
6315	SUPPL	2015-03-19
28721	SUPPL	2013-04-24
28717	SUPPL	2013-04-24
6314	SUPPL	2013-04-24
37767	SUPPL	2013-04-23
37766	SUPPL	2013-04-23
16465	SUPPL	2013-04-23
28719	SUPPL	2011-08-12
28720	SUPPL	2011-07-07
28718	SUPPL	2011-01-27
16464	SUPPL	2011-01-26
44156	ORIG	2008-01-07
21844	ORIG	2007-05-09
6313	SUPPL	2007-02-23
16463	SUPPL	2006-08-09
6312	SUPPL	2006-08-09
16462	ORIG	2006-01-10
6311	ORIG	2006-01-10