Home Applications 019778 Application 019778
Type NDA
Sponsor MERCK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019778-001 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 N019778-002 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 N019778-003 PRINZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-11-18
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UTC 2022-10 N019778-001 PRINZIDE 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019778-002 PRINZIDE 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019778-003 PRINZIDE 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019778-001 PRINZIDE 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019778-002 PRINZIDE 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019778-003 PRINZIDE 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-11-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019778-001 PRINZIDE 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019778-002 PRINZIDE 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019778-003 PRINZIDE 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-11-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019778-001 PRINZIDE 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019778-002 PRINZIDE 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1989-02-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019778-003 PRINZIDE 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-11-18 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.