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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 020286

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NDA 020286 describes MONOPRIL-HCT, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the MONOPRIL-HCT profile page.

The generic ingredient in MONOPRIL-HCT is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 020286
Paragraph IV (Patent) Challenges for 020286
Tradename Dosage Ingredient NDA Submissiondate
MONOPRIL-HCT TABLET;ORAL fosinopril sodium; hydrochlorothiazide 020286

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 30, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 30, 1994TE:RLD:Yes

Expired US Patents for NDA 020286

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Serving leading biopharmaceutical companies globally:

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