FDA.reportPublic FDA data

Application 204051

Type
ANDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INJECTION4MG/100MLNoNo

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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45503ORIG2016-10-06