Application 020070

Type
NDA
Sponsor
SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COGNEXTACRINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002COGNEXTACRINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
003COGNEXTACRINE HYDROCHLORIDECAPSULE;ORALEQ 30MG BASENoNo
004COGNEXTACRINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020070-001COGNEXTACRINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1993-09-09
N020070-002COGNEXTACRINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORAL1993-09-09
N020070-003COGNEXTACRINE HYDROCHLORIDEEQ 30MG BASECAPSULE / ORAL1993-09-09
N020070-004COGNEXTACRINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORAL1993-09-09

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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09d06236e962d9…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21104SUPPL2003-06-22
1983SUPPL2003-06-22
41140SUPPL1997-10-10
41139SUPPL1997-10-10