FDA.reportPublic FDA data

Application 008693

Type
NDA
Sponsor
PROCTER AND GAMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FURADANTINNITROFURANTOINTABLET;ORAL50MGNoNo
002FURADANTINNITROFURANTOINTABLET;ORAL100MGNoNo

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

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
N008693-001FURADANTINNITROFURANTOIN50MGTABLET / ORALApproved before 1982
N008693-002FURADANTINNITROFURANTOIN100MGTABLET / ORALApproved before 1982

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N008693-001FURADANTIN50MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N008693-002FURADANTIN100MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008693-001FURADANTIN50MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N008693-002FURADANTIN100MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008693-001FURADANTIN50MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008693-002FURADANTIN100MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008693-001FURADANTIN50MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008693-002FURADANTIN100MGTABLET / ORALApproved before 1982a50c72e98297…

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROFURANTOINNITROFURANTOINREMEDYREPACK INC.87505f8f-2056-4e55-adf5-5b7309081d7c2026-09-01Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINREMEDYREPACK INC.6c82b95d-2c32-4e54-a8a9-a4bb4df70cb52026-08-19Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINPreferred Pharmaceuticals Inc.729f6bbb-ab64-4b65-979a-4ad7605c59472026-08-04Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINSt. Mary's Medical Park Pharmacy09944470-807d-ad37-e063-6394a90a7bfe2026-06-23Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINSomerset Therapeutics, LLCdd99ba40-edff-47c3-9ee4-7e5b7774e5b52026-01-22Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINRising Pharma Holdings, Inc.89095f4d-e142-465e-b378-da24f6eeaf2b2025-11-11Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINBryant Ranch Prepack1c5db054-58af-4932-8fad-c3883b13f9872025-10-22Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.d88348a0-6ab4-4490-9325-1f14a541b0a52025-10-14Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.37606c6f-0d85-4314-94ae-f7732c7bc8d52025-10-09Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NITROFURANTOINNITROFURANTOINProficient Rx LP0819be0b-03e9-426e-a4b9-624c32958f942025-09-01Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NITROFURANTOINNITROFURANTOINCamber Pharmaceuticals, Inc.4e06b31e-cc49-4526-beb6-e77021823aa92025-08-13Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINMicro Labs Limitedd96098d0-3c2b-4e53-a3f0-3ebba81c41332025-05-14Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINRedpharm Drug, Inc.f4c2c01d-bef7-3e5d-e053-2995a90ae0d82025-01-23Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NITROFURANTOINNITROFURANTOINDirectrxd4385368-46d6-8397-e053-2a95a90a8d682025-01-17Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NITROFURANTOINNITROFURANTOINBiocon Pharma Inc68c718a7-2e8f-288c-37d2-053372ee61b92024-11-14Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINAmneal Pharmaceuticals LLC11dcea9c-0c62-4153-976b-bd1f8ef1f6d92024-10-30Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINANI Pharmaceuticals, Inc.3b377aff-2d4b-43ea-84c9-8e72c1421b7b2024-10-08Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINBryant Ranch Prepack56e07ad3-7224-4aaf-9a68-0d48d4abfec82024-08-28Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINRising Pharma Holdings, Inc.11e700aa-66f9-4939-8a6b-a23240ae1a0b2024-05-16Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN
NitrofurantoinNITROFURANTOINNorthStar Rx LLC04af8b73-7e15-7da8-e063-6294a90af2842024-03-29Warnings, Adverse reactionsName fallback
generic name: NITROFURANTOIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20014SUPPL2006-05-10