Home Applications 017681 Application 017681
Type NDA
Sponsor US PHARM HOLDINGS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HIPREX METHENAMINE HIPPURATE TABLET;ORAL 1GM Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017681-001 HIPREX METHENAMINE HIPPURATE 1GM TABLET / ORAL AB RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017681-001 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 · 44 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 2022-10-28 04:53 UTC 2022-10 N017681-001 HIPREX 1GM TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017681-001 HIPREX 1GM TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017681-001 HIPREX 1GM TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017681-001 HIPREX 1GM TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 0955-1037 Methenamine Hippurate Methenamine Hippurate Winthrop U.S. NDA Current 30698-277 HIPREX Methenamine Hippurate Validus Pharmaceuticals LLC NDA Current 30698-277 HIPREX Methenamine Hippurate Validus Pharmaceuticals LLC NDA Current 30698-477 HIPREX Methenamine Hippurate Validus Pharmaceuticals LLC NDA Current 69315-210 Methenamine Hippurate Methenamine Hippurate Leading Pharma, LLC NDA AUTHORIZED GENERIC Current 69315-210 Methenamine Hippurate Methenamine Hippurate Leading Pharma, LLC NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 70234 SUPPL 2022-02-23 70186 SUPPL 2022-02-18 50592 SUPPL 2017-12-04 50581 SUPPL 2017-12-01 33330 SUPPL 2005-11-30 682 SUPPL 2005-11-30 33329 SUPPL 2004-06-15 681 SUPPL 2004-06-15