Home Applications 019174 Application 019174
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;100MG No No 002 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;200MG No No 003 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;300MG No No 004 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019174-001 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE 25MG;100MG TABLET / ORAL 1987-04-10 N019174-002 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE 25MG;200MG TABLET / ORAL 1987-04-10 N019174-003 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE 25MG;300MG TABLET / ORAL 1987-04-10 N019174-004 TRANDATE HCT HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE 25MG;400MG TABLET / ORAL 1987-04-10
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 5 · 172 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 2026-09-14 22:38:34 2026-08 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.