FDA.reportPublic FDA data

Application 020403

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020403-001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERONDANSETRON HYDROCHLORIDEEQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-01-31

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020403-001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINEREQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020403-001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINEREQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020403-001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINEREQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-01-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020403-001ZOFRAN AND DEXTROSE IN PLASTIC CONTAINEREQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-01-31a50c72e98297…

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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24914SUPPL2011-09-16
12540SUPPL2011-09-16
2483SUPPL2011-07-13
34605SUPPL2011-07-12
12539SUPPL2010-09-29
24913SUPPL2010-09-28
41338SUPPL2009-09-16
20634SUPPL2009-01-12
24912SUPPL2006-09-18
34604SUPPL2006-08-23
24911SUPPL2006-01-06
12538SUPPL2006-01-05
12537SUPPL2004-12-03
24910SUPPL2004-12-02
41337SUPPL1997-10-31