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001 THALITONE CHLORTHALIDONE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 THALITONE CHLORTHALIDONE TABLET;ORAL 25MG No No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 42 .
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date N019574-001 THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 N019574-002 THALITONE CHLORTHALIDONE 25MG TABLET / ORAL RLD 1992-02-12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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019574-002 THALITONE 25MG TABLET / ORAL RLD 1992-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 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 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 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 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 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 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 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 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 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 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 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 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 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 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 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 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 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 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 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 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 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 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019574-001 THALITONE 15MG TABLET / ORAL RLD 1988-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019574-001 THALITONE 15MG TABLET / ORAL RLD 1988-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1988-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019574-002 THALITONE 25MG TABLET / ORAL 1992-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 bb7c543d1eb4…
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.
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