FDA.reportPublic FDA data

Application 078580

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

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

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoledronic AcidZOLEDRONIC ACIDDr. Reddy's Laboratories Limited1738a682-5903-b675-3a7a-61d299a6f2482023-10-30Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDMylan Institutional LLC20cd29cc-cef5-48c4-adfe-6b3dfee0ab612023-10-18Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDFresenius Kabi USA, LLC16fcf8c9-ef8a-4e93-9ee6-acfadd35a8612023-09-21Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.00a5bd5a-e5ee-4bad-b510-a4d4485485c82023-09-18Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDNORTHSTAR RX LLC3885488c-6b83-421b-afee-61abceb956342023-09-06Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDFresenius Kabi USA, LLCf3f9de47-3d85-4d0c-a29e-1635cad3a9702023-08-24Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDBluePoint Laboratories666b1833-ee9b-4a6f-bd4c-9526552cec0a2023-07-27Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDMeitheal Pharmaceuticals Inc.8aac81ae-f92c-4f0b-b480-44badf72b5f52023-06-12Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDWestminster Pharmaceuticals, LLC6a153c94-3cb5-4c05-98b2-1e18f5f3fe802023-02-02Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDAuroMedics Pharma LLCac7ff1eb-6e73-4cc8-9114-c5a4483ad4c32021-11-29Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
zoledronic acidZOLEDRONIC ACIDSagent Pharmaceuticalsdeb89be7-f40e-4fd4-a2cb-96634b45da842021-09-20Warnings, Adverse reactionsName fallback
brand name: zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDHikma Pharmaceuticals USA Inc.784d33fa-0046-42eb-894b-3fc47dcfd4dc2021-01-01Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDGland Pharma Limited1740d7d8-a101-4688-8d8b-beb00559d6022019-04-02Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic acidZOLEDRONIC ACIDDr. Reddy's Laboratories Incb165df31-52f0-d67f-71e7-f3b4f18d2f152018-05-16Warnings, Adverse reactionsName fallback
brand name: Zoledronic acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDDr.Reddy's Laboratories Incc8e02635-4473-8ba2-248f-ced58dbeabce2017-07-20Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9168ORIG2013-03-04