Home Applications 018709 Application 018709
Type NDA
Sponsor APOTHECON Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAPOZIDE 25/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 CAPOZIDE 25/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 CAPOZIDE 50/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 CAPOZIDE 50/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018709-001 CAPOZIDE 25/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 N018709-002 CAPOZIDE 25/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 N018709-003 CAPOZIDE 50/25 CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 N018709-004 CAPOZIDE 50/15 CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12
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 5 of 5 · 176 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 N018709-001 CAPOZIDE 25/15 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018709-002 CAPOZIDE 25/25 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018709-003 CAPOZIDE 50/25 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018709-004 CAPOZIDE 50/15 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018709-001 CAPOZIDE 25/15 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018709-002 CAPOZIDE 25/25 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018709-003 CAPOZIDE 50/25 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018709-004 CAPOZIDE 50/15 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018709-001 CAPOZIDE 25/15 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018709-002 CAPOZIDE 25/25 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018709-003 CAPOZIDE 50/25 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018709-004 CAPOZIDE 50/15 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018709-001 CAPOZIDE 25/15 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018709-002 CAPOZIDE 25/25 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018709-003 CAPOZIDE 50/25 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018709-004 CAPOZIDE 50/15 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-10-12 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 1044 SUPPL 2009-03-03 1043 SUPPL 2006-05-21