Home Applications 009175 Application 009175
Type NDA
Sponsor CASPER PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FURADANTIN NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML Yes Yes 002 FURADANTIN NITROFURANTOIN SUSPENSION;ORAL 50MG/5ML Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N009175-001 FURADANTIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 N009175-002 FURADANTIN NITROFURANTOIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N009175-001 AB
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 · 68 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009175-001 FURADANTIN 25MG/5ML SUSPENSION / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009175-002 FURADANTIN 50MG/5ML SUSPENSION / ORAL RLD, RS 2023-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16571-740 Nitrofurantoin Nitrofurantoin Rising Pharma Holdings, Inc. NDA AUTHORIZED GENERIC Current 16571-740 Nitrofurantoin Nitrofurantoin Rising Pharma Holdings, Inc. NDA AUTHORIZED GENERIC Current 59630-450 Furadantin nitrofurantoin Shionogi Inc. NDA Current 70199-006 Furadantin Nitrofurantoin Casper Pharma LLC NDA Current 70199-006 Furadantin Nitrofurantoin Casper Pharma LLC NDA Current 70199-006 Furadantin Nitrofurantoin Casper Pharma LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77388 SUPPL 2024-03-04 77383 SUPPL 2024-02-02 75516 SUPPL 2023-09-20 75513 SUPPL 2023-09-19 65926 SUPPL 2021-01-19 65925 SUPPL 2021-01-19 59040 SUPPL 2019-06-12 59018 SUPPL 2019-06-12 32991 SUPPL 2016-03-18 11868 SUPPL 2013-11-07 32989 SUPPL 2013-11-04 131 SUPPL 2010-11-02 132 SUPPL 2010-10-19 130 SUPPL 2009-02-13 32990 SUPPL 2009-02-10 11867 SUPPL 2008-06-03 20018 SUPPL 2006-05-10