Home Applications 020070 Application 020070
Type NDA
Sponsor SHIONOGI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COGNEX TACRINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No 002 COGNEX TACRINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE No No 003 COGNEX TACRINE HYDROCHLORIDE CAPSULE;ORAL EQ 30MG BASE No No 004 COGNEX TACRINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE 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 N020070-001 COGNEX TACRINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1993-09-09 N020070-002 COGNEX TACRINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 1993-09-09 N020070-003 COGNEX TACRINE HYDROCHLORIDE EQ 30MG BASE CAPSULE / ORAL 1993-09-09 N020070-004 COGNEX TACRINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 1993-09-09
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 3 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 2019-12-13 00:20 UTC 2019-12 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020070-001 COGNEX EQ 10MG BASE CAPSULE / ORAL 1993-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020070-002 COGNEX EQ 20MG BASE CAPSULE / ORAL 1993-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020070-003 COGNEX EQ 30MG BASE CAPSULE / ORAL 1993-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020070-004 COGNEX EQ 40MG BASE CAPSULE / ORAL 1993-09-09 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 21104 SUPPL 2003-06-22 1983 SUPPL 2003-06-22 41140 SUPPL 1997-10-10 41139 SUPPL 1997-10-10