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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020070-001COGNEXEQ 10MG BASECAPSULE / ORAL1993-09-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020070-002COGNEXEQ 20MG BASECAPSULE / ORAL1993-09-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020070-003COGNEXEQ 30MG BASECAPSULE / ORAL1993-09-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020070-004COGNEXEQ 40MG BASECAPSULE / ORAL1993-09-094b0b4de00fa7…

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