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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2020-11-12 02:37 UTC2020-11N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N014740-002MENRIUM 5-25MG;0.2MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N014740-004MENRIUM 5-45MG;0.4MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N014740-006MENRIUM 10-410MG;0.4MGTABLET / ORALApproved before 19823a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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