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 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 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 4 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 2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019174-001 TRANDATE HCT 25MG;100MG TABLET / ORAL 1987-04-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019174-002 TRANDATE HCT 25MG;200MG TABLET / ORAL 1987-04-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019174-003 TRANDATE HCT 25MG;300MG TABLET / ORAL 1987-04-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019174-004 TRANDATE HCT 25MG;400MG TABLET / ORAL 1987-04-10 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.