Home Applications 019574 Application 019574
Type NDA
Sponsor CASPER PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 THALITONE CHLORTHALIDONE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 THALITONE CHLORTHALIDONE TABLET;ORAL 25MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019574-001 THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 N019574-002 THALITONE CHLORTHALIDONE 25MG TABLET / ORAL RLD 1992-02-12
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N019574-002 THALITONE 25MG TABLET / ORAL RLD 1992-02-12 a50c72e98297…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61570-024 THALITONE chlorthalidone Monarch Pharmaceuticals, Inc NDA Current 70199-001 Thalitone chlorthalidone Casper Pharma LLC NDA Current 70199-017 Thalitone Chlorthalidone Casper Pharma LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60031 SUPPL 2019-09-18 60030 SUPPL 2019-09-18 53825 SUPPL 2018-04-27 1395 SUPPL 2004-06-07