FDA.reportPublic FDA data

Application 021858

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BONIVAIBANDRONATE SODIUMINJECTABLE;INTRAVENOUSEQ 3MG BASE/3MLYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021858-001BONIVAIBANDRONATE SODIUMEQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2006-01-06

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021858-001BONIVAEQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2006-01-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021858-001BONIVAEQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2006-01-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021858-001BONIVAEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSRLD2006-01-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021858-001BONIVAEQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2006-01-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021858-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021858-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021858-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021858-001AP1ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBANDRONATE SODIUMIBANDRONATE SODIUMBionpharma Inc.6ca94cce-a2bb-421f-bd8f-6b14bc2bd9852026-08-26Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
Ibandronate SodiumIBANDRONATE SODIUMAurobindo Pharma Limited86c0b4ae-5e38-4efe-88af-50ac560e294f2026-03-18Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUMIBANDRONATE SODIUMSun Pharmaceutical Industries, Inc.be514be6-727a-4d6c-993b-52144f8e6de82026-03-03Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUMIBANDRONATE SODIUMGolden State Medical Supply, Inc.618e1aff-ccbb-4cee-93f1-fe04e33dacb72026-02-19Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
Ibandronate sodiumIBANDRONATE SODIUMDr. Reddy's Laboratories Limitedf94d9c49-245a-8081-42c4-785113fce4982026-02-16Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
Ibandronate SodiumIBANDRONATE SODIUMEugia US LLCe81f2c5b-bead-48ac-be3e-016cf963d7ed2026-01-27Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
IBANDRONATE SODIUMIBANDRONATE SODIUMMacleods Pharmaceuticals Limiteda5741ef6-0599-4657-8cda-2902ded4f6802026-01-19Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
Ibandronate SodiumIBANDRONATE SODIUMApotex Corp.9fad4982-95af-d711-f50a-8673118351432026-01-15Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM
Ibandronate sodiumIBANDRONATE SODIUMA-S Medication Solutionse5b6c2a9-a55f-41f9-a592-e26ef03e2d732025-09-22Warnings, Adverse reactionsName fallback
generic name: IBANDRONATE SODIUM

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69846SUPPL2022-01-12
69845SUPPL2022-01-12
46648SUPPL2017-01-03
46141SUPPL2016-12-13
46105SUPPL2016-12-09
6316SUPPL2015-04-13
37769SUPPL2015-04-10
37768SUPPL2015-03-19
6315SUPPL2015-03-19
28721SUPPL2013-04-24
28717SUPPL2013-04-24
6314SUPPL2013-04-24
37767SUPPL2013-04-23
37766SUPPL2013-04-23
16465SUPPL2013-04-23
28719SUPPL2011-08-12
28720SUPPL2011-07-07
28718SUPPL2011-01-27
16464SUPPL2011-01-26
44156ORIG2008-01-07
21844ORIG2007-05-09
6313SUPPL2007-02-23
16463SUPPL2006-08-09
6312SUPPL2006-08-09
16462ORIG2006-01-10
6311ORIG2006-01-10