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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019915

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NDA 019915 describes MONOPRIL, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional details are available on the MONOPRIL profile page.

The generic ingredient in MONOPRIL is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 019915
Tradename:MONOPRIL
Applicant:Bristol Myers Squibb
Ingredient:fosinopril sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019915
Paragraph IV (Patent) Challenges for 019915
Tradename Dosage Ingredient NDA Submissiondate
MONOPRIL TABLET;ORAL fosinopril sodium 019915

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 16, 1991TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 16, 1991TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 28, 1995TE:RLD:Yes

Expired US Patents for NDA 019915

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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