Application 014740

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MENRIUM 5-2CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIEDTABLET;ORAL5MG;0.2MGNoNo
004MENRIUM 5-4CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIEDTABLET;ORAL5MG;0.4MGNoNo
006MENRIUM 10-4CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIEDTABLET;ORAL10MG;0.4MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N014740-002MENRIUM 5-2CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED5MG;0.2MGTABLET / ORALApproved before 1982
N014740-004MENRIUM 5-4CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED5MG;0.4MGTABLET / ORALApproved before 1982
N014740-006MENRIUM 10-4CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED10MG;0.4MGTABLET / ORALApproved before 1982

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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