Home Applications 020729 Application 020729
Type NDA
Sponsor UCB INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 002 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 003 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020729-001 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 N020729-002 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 N020729-003 UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-02-14
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 4 of 4 · 132 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 N020729-001 UNIRETIC 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020729-002 UNIRETIC 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020729-003 UNIRETIC 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020729-001 UNIRETIC 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020729-002 UNIRETIC 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020729-003 UNIRETIC 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-02-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020729-001 UNIRETIC 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020729-002 UNIRETIC 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020729-003 UNIRETIC 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-02-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020729-001 UNIRETIC 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020729-002 UNIRETIC 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020729-003 UNIRETIC 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-02-14 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 25652 SUPPL 2012-09-17 35246 SUPPL 2012-09-14 35245 SUPPL 2012-01-23 3220 SUPPL 2012-01-23 13305 SUPPL 2011-09-02 25651 SUPPL 2011-08-26 35244 SUPPL 2011-05-23 35243 SUPPL 2010-01-20 25650 SUPPL 2010-01-15 20885 SUPPL 2007-09-26 25649 SUPPL 2003-11-25 3219 SUPPL 2002-02-14