FDA.reportPublic FDA data

Application 050664

Type
NDA
Sponsor
CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFZILCEFPROZILTABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CEFZILCEFPROZILTABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050664-001CEFZILCEFPROZIL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-12-23
N050664-002CEFZILCEFPROZIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-12-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050664-001CEFZIL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-12-23a50c72e98297…
2026-08-01 22:54:322026-06N050664-002CEFZIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-12-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefprozilCEFPROZILNorthStar Rx LLC8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb42026-07-09Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.800a2ec0-4798-4423-9613-d03024cf1f0e2026-05-04Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.3ec55c0a-1456-412e-972f-352b3135c8f22025-10-10Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.14527f4a-ce99-449d-a5a5-9edd7fb28dee2025-10-10Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILAscend Laboratories, LLCdc3e9cae-6f4f-4045-a11e-2fbf7f94c3c02025-05-30Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILA-S Medication Solutionsd5d28d57-1f3c-4c80-ad78-0f67635f54282025-01-30Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILRising Pharma Holdings, Inc.d7fac9cc-30e1-4762-a01b-04f1bd3b2a562024-05-18Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILAurobindo Pharma Limited97675251-70b8-43bc-93ea-f9ef6bb8cb682024-05-18Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILNorthStar Rx LLC6133611e-19c1-4df2-8c23-8573aaf630202024-05-05Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILAurobindo Pharma Limitedb9111a81-07c4-4458-b994-a4ad504986d82024-05-05Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILRising Pharma Holdings, Inc.af24a86f-8072-49a6-94ec-2f17fe81812b2024-05-05Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILA-S Medication Solutions8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46d2024-01-26Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL
CefprozilCEFPROZILTeva Pharmaceuticals USA, Inc.3391de8b-7bc9-4624-a5c4-836135b39d992018-08-31Warnings, Adverse reactionsName fallback
generic name: CEFPROZIL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45974SUPPL2016-12-01
45952SUPPL2016-11-23
30246SUPPL2007-09-25
39081SUPPL2007-09-19
17993SUPPL2004-06-25
7955SUPPL2004-06-25