Details for New Drug Application (NDA): 018303

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NDA 018303 describes LOPRESSOR HCT, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LOPRESSOR HCT profile page.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for 018303

Tradename:	LOPRESSOR HCT
Applicant:	Validus Pharms
Ingredient:	hydrochlorothiazide; metoprolol tartrate
Patents:	0

Pharmacology for NDA: 018303

Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 018303

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303	NDA	Validus Pharmaceuticals LLC	30698-461	30698-461-01	100 TABLET in 1 BOTTLE (30698-461-01)
LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303	NDA	Validus Pharmaceuticals LLC	30698-462	30698-462-01	100 TABLET in 1 BOTTLE (30698-462-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;50MG
Approval Date:	Dec 31, 1984	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1984	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 018303

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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