FDA.reportPublic FDA data

Application 201801

Type
ANDA
Sponsor
EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 5MG BASE/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201801-001ZOLEDRONIC ACIDZOLEDRONIC ACIDEQ 5MG BASE/100MLINJECTABLE / INTRAVENOUS2013-03-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A201801-001ZOLEDRONIC ACIDEQ 5MG BASE/100MLINJECTABLE / INTRAVENOUS2013-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201801-001ZOLEDRONIC ACIDEQ 5MG BASE/100MLINJECTABLE / INTRAVENOUS2013-03-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201801-001ZOLEDRONIC ACIDEQ 5MG BASE/100MLINJECTABLE / INTRAVENOUS2013-03-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A201801-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A201801-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A201801-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201801-001AP1ea99ee380514…

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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoledronic AcidZOLEDRONIC ACIDMeitheal Pharmaceuticals Inc.8aac81ae-f92c-4f0b-b480-44badf72b5f52026-07-09Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID
Zoledronic AcidZOLEDRONIC ACIDEugia US LLCbf5f96d4-f87c-4968-bed0-a4b5e77f41622026-05-15Warnings, 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 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
Zoledronic AcidZOLEDRONIC ACIDDr. Reddy's Laboratories Limited1738a682-5903-b675-3a7a-61d299a6f2482023-10-30Warnings, Adverse reactionsName fallback
brand name: Zoledronic Acid
generic name: ZOLEDRONIC ACID

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-186Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc.ANDACurrent
23155-525Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22860ORIG2013-05-02