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 44.

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-096a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-096a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-096a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-091c564ffb4f44…
2024-02-18 07:12 UTC2024-02N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-091c564ffb4f44…
2024-02-18 07:12 UTC2024-02N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-091c564ffb4f44…
2024-02-18 07:12 UTC2024-02N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-099b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-099b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-099b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-093f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-093f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-093f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09053a50430f4f…
2023-05-13 08:27 UTC2023-05N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09053a50430f4f…
2023-05-13 08:27 UTC2023-05N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09053a50430f4f…
2023-05-13 08:27 UTC2023-05N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-093a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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