FDA.reportPublic FDA data

Application 090709

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE; IV (INFUSION)EQ 4MG BASE/5MLNoNo

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoledronic AcidZOLEDRONIC ACIDEugia US LLCbf5f96d4-f87c-4968-bed0-a4b5e77f41622026-05-15Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDBluePoint Laboratories5de65a7f-a219-4b22-9155-61fedc84433b2026-04-13Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDMylan Institutional LLC80006f10-85a3-4390-b5dc-3b2097134f3d2026-03-18Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDMylan Institutional LLC1977d713-4cc7-405e-b4c1-a9a91635eff62026-03-16Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDGland Pharma Limitedd761011b-edd6-4d3f-bacd-8607dc2414fc2026-02-27Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDFOSUN PHARMA USA INCfd0324d8-b9bd-fd4c-e053-6394a90a54652026-02-26Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDGland Pharma Limited824eaeee-6b3d-4d62-b268-77f8bd8e7f102026-02-24Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
zoledronic acidZOLEDRONIC ACIDGland Pharma Limited46c3a880-3723-45cf-979e-57ef6391662e2026-02-06Warnings, Adverse reactionsName fallback
brand name: zoledronic acid
generic name: ZOLEDRONIC ACID
ReclastZOLEDRONIC ACIDSandoz Inc5a9b3737-9ce6-4a89-b76e-6aab79eba9cf2026-02-03Warnings, Adverse reactionsName fallback
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDBPI Labs LLC1b556f75-9174-4798-8c8d-21cf34beac132025-12-26Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDAccord Healthcare Inc.3df715a1-2562-4374-a383-6edc33c6e52f2025-10-08Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDBPI Labs LLC634e9d4b-e940-4743-ad39-794dad28d79b2025-10-03Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDBluePoint Laboratoriesf433c13c-dd8c-4dca-834e-a4ecf09d1eab2025-09-03Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
zoledronic acidZOLEDRONIC ACIDSagent Pharmaceuticals567578e6-cd2d-4339-b0f6-7a15444c06392025-03-11Warnings, Adverse reactionsName fallback
brand name: zoledronic acid
generic name: ZOLEDRONIC ACID
zoledronic acidZOLEDRONIC ACIDSagent Pharmaceuticals164500d7-51cf-438a-8bee-7a7dce76ad7a2025-03-11Warnings, Adverse reactionsName fallback
brand name: zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDAvenacy Inc.4b699dd8-d232-4bdb-88ce-9b42ed93e0362025-01-15Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDDr.Reddy's Laboratories Ltdf94a5c9e-74bc-d09e-cd65-394b2a5de2ad2024-11-01Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDGland Pharma Limited7a5e8962-7c4b-40bb-ad69-0c3edb0338af2023-11-15Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDDr. Reddy's Laboratories Inc.bbb29627-76b5-e742-0e79-ef3bf22021b82023-10-30Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDDr. Reddy's Laboratories Inc.72623e70-9db3-f1b8-de7d-c1a61d71fb012023-10-30Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID