FDA.reportPublic FDA data

Application 078014

Type
ANDA
Sponsor
TARO PHARMS IRELAND

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

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
A078014-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-03-21

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 UTC2022-09A078014-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-03-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078014-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-03-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078014-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2008-03-21a50c72e98297…

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 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ondansetronONDANSETRON HYDROCHLORIDEMajor Pharmaceuticalsa29b5c18-9884-4c88-8827-65d9ad5f69f62026-08-21Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetronONDANSETRON HYDROCHLORIDEBryant Ranch Prepack37de0550-a6d1-46a8-a0b8-447b0dcf70ad2026-08-19Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.5566aebb-d84d-6d6a-e063-6294a90a746f2026-08-18Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.2a30d534-4607-4882-865e-56d2364acaad2026-08-07Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy00b17a8e-9d38-a8d4-e063-6294a90a153e2026-08-05Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEProficient Rx LP0a14eb9a-0385-40e9-a7ec-71435450ac912026-08-01Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy57b0a1e5-5dfa-64a0-e063-6394a90acf362026-07-24Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEIpca Laboratories Limited7ab3210e-eed1-479a-afc0-f72b5b7768832026-07-22Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetronONDANSETRON HYDROCHLORIDEAscend Laboratories, LLC2edc0788-dc38-4d21-ba8e-71f159e2d3b12026-07-22Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepack3f2e8efe-7fd4-407c-a77b-bd6dd04608e22026-07-10Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.ee3e8cbe-4f0b-4361-a1b5-8329d85a29322026-07-08Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.561dce26-92fa-e00b-e063-6294a90a1ab22026-07-08Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy58f16a00-3e66-29de-e053-2991aa0a59a02026-06-26Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAmerican Health Packaging9f015e60-1aec-4ae7-b28f-42f6c8f504552026-06-25Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECoupler LLC546191d2-d092-6342-e063-6294a90a0cd32026-06-16Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERedpharm Drug541b9a0d-ae94-db6f-e063-6394a90a98052026-06-12Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESportpharm LLCc0be25a0-e13d-4242-93dc-0b86e82aadd72026-04-24Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.5cc67d95-6629-4451-9e34-2f7a60482be52026-04-10Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESportpharm LLCb1324076-f83e-4816-9e02-6b2a689010bc2026-04-05Warnings, Adverse reactionsName fallback
generic name: ONDANSETRON HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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