Home Applications 019979 Application 019979
Type NDA
Sponsor ROCHE PALO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TICLID TICLOPIDINE HYDROCHLORIDE TABLET;ORAL 125MG No No 002 TICLID TICLOPIDINE HYDROCHLORIDE TABLET;ORAL 250MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019979-001 TICLID TICLOPIDINE HYDROCHLORIDE 125MG TABLET / ORAL 1993-03-24 N019979-002 TICLID TICLOPIDINE HYDROCHLORIDE 250MG TABLET / ORAL 1991-10-31
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019979-001 TICLID 125MG TABLET / ORAL 1993-03-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019979-002 TICLID 250MG TABLET / ORAL 1991-10-31 bb7c543d1eb4…
Documents# Document, Submission type, Date table Document Submission type Date 20437 SUPPL 2001-12-18 20438 SUPPL 2001-06-04 34170 SUPPL 2001-04-18 1881 SUPPL 2001-04-18