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Last Updated: November 21, 2024

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

Summary for 020286

Tradename:	MONOPRIL-HCT
Applicant:	Bristol Myers Squibb
Ingredient:	fosinopril sodium; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 30, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 30, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020286

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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