FDA.reportPublic FDA data

Application 079194

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBANDRONATE SODIUMIBANDRONATE SODIUMINJECTABLE; INJECTION1MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9235ORIG2009-04-09