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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. Seven suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for NDA: 019915

Bristol Myers Squibb
fosinopril sodium
Therapeutic Class:Cardiovascular Agents

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:May 16, 1991TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:May 16, 1991TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Mar 28, 1995TE:RLD:No

Expired Orange Book Patents for NDA: 019915

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
fosinopril sodium
TABLET;ORAL019915-002May 16, 19914,337,201*PED► subscribe
Bristol Myers Squibb
fosinopril sodium
TABLET;ORAL019915-004Mar 28, 19954,337,201*PED► subscribe
Bristol Myers Squibb
fosinopril sodium
TABLET;ORAL019915-003May 16, 19914,384,123► subscribe
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