Home Applications 018166 Application 018166
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRASICOR OXPRENOLOL HYDROCHLORIDE CAPSULE;ORAL 20MG No No 002 TRASICOR OXPRENOLOL HYDROCHLORIDE CAPSULE;ORAL 40MG No No 003 TRASICOR OXPRENOLOL HYDROCHLORIDE CAPSULE;ORAL 80MG No No 004 TRASICOR OXPRENOLOL HYDROCHLORIDE CAPSULE;ORAL 160MG 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 N018166-001 TRASICOR OXPRENOLOL HYDROCHLORIDE 20MG CAPSULE / ORAL 1983-12-28 N018166-002 TRASICOR OXPRENOLOL HYDROCHLORIDE 40MG CAPSULE / ORAL 1983-12-28 N018166-003 TRASICOR OXPRENOLOL HYDROCHLORIDE 80MG CAPSULE / ORAL 1983-12-28 N018166-004 TRASICOR OXPRENOLOL HYDROCHLORIDE 160MG CAPSULE / ORAL 1983-12-28
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 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018166-001 TRASICOR 20MG CAPSULE / ORAL 1983-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018166-002 TRASICOR 40MG CAPSULE / ORAL 1983-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018166-003 TRASICOR 80MG CAPSULE / ORAL 1983-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018166-004 TRASICOR 160MG CAPSULE / ORAL 1983-12-28 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.