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. Two 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

Medical Subject Heading (MeSH) Categories for 019915

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 16, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 16, 1991	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 28, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 019915

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	4,384,123	⤷ Subscribe
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	5,006,344*PED	⤷ Subscribe
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991	4,337,201*PED	⤷ Subscribe
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	4,337,201*PED	⤷ Subscribe
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	5,006,344*PED	⤷ Subscribe
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	4,337,201*PED	⤷ Subscribe
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