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Details for New Drug Application (NDA): 014740

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NDA 014740 describes MENRIUM 5-4, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the MENRIUM 5-4 profile page.

The generic ingredient in MENRIUM 5-4 is chlordiazepoxide; estrogens, esterified. There are eight drug master file entries for this compound. Additional details are available on the chlordiazepoxide; estrogens, esterified profile page.

Summary for NDA: 014740

chlordiazepoxide; estrogens, esterified
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;0.2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;0.4MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;0.4MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 014740

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
chlordiazepoxide; estrogens, esterified
TABLET;ORAL014740-006Approved Prior to Jan 1, 19824,316,897<disabled>
chlordiazepoxide; estrogens, esterified
TABLET;ORAL014740-004Approved Prior to Jan 1, 19824,316,897<disabled>
chlordiazepoxide; estrogens, esterified
TABLET;ORAL014740-002Approved Prior to Jan 1, 19824,316,897<disabled>
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