FDA.reportPublic FDA data

Application 009175

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FURADANTINNITROFURANTOINSUSPENSION;ORAL25MG/5MLYesYes
002FURADANTINNITROFURANTOINSUSPENSION;ORAL50MG/5MLYesYes

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
N009175-001FURADANTINNITROFURANTOIN25MG/5MLSUSPENSION / ORALABRLD, Approved before 1982
N009175-002FURADANTINNITROFURANTOIN50MG/5MLSUSPENSION / ORALRLD, RS2023-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N009175-001AB

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 22:54:322026-06N009175-001FURADANTIN25MG/5MLSUSPENSION / ORALABRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N009175-002FURADANTIN50MG/5MLSUSPENSION / ORALRLD, RS2023-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N009175-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrofurantoinNITROFURANTOINRising Pharma Holdings, Inc.89095f4d-e142-465e-b378-da24f6eeaf2b2025-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 009175
application number: NDA009175
ndc (product): 16571-740

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-740NitrofurantoinNitrofurantoinRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-740NitrofurantoinNitrofurantoinRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
59630-450FuradantinnitrofurantoinShionogi Inc.NDACurrent
70199-006FuradantinNitrofurantoinCasper Pharma LLCNDACurrent
70199-006FuradantinNitrofurantoinCasper Pharma LLCNDACurrent
70199-006FuradantinNitrofurantoinCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77388SUPPL 2024-03-04
77383SUPPL 2024-02-02
75516SUPPL 2023-09-20
75513SUPPL 2023-09-19
65926SUPPL2021-01-19
65925SUPPL2021-01-19
59040SUPPL2019-06-12
59018SUPPL2019-06-12
32991SUPPL2016-03-18
11868SUPPL2013-11-07
32989SUPPL2013-11-04
131SUPPL2010-11-02
132SUPPL2010-10-19
130SUPPL2009-02-13
32990SUPPL2009-02-10
11867SUPPL2008-06-03
20018SUPPL2006-05-10