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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
IBANDRONATE SODIUMIBANDRONATE SODIUMBionpharma Inc.6ca94cce-a2bb-421f-bd8f-6b14bc2bd9852023-05-23Warnings, Adverse reactionsName fallback
brand name: IBANDRONATE SODIUM
generic name: IBANDRONATE SODIUM

Documents#

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