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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 018760

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NDA 018760 describes TENORETIC 50, which is a drug marketed by Twi Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TENORETIC 50 profile page.

The generic ingredient in TENORETIC 50 is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.

Summary for 018760

Tradename:	TENORETIC 50
Applicant:	Twi Pharms
Ingredient:	atenolol; chlorthalidone
Patents:	0

Pharmacology for NDA: 018760

Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 018760

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Almatica Pharma LLC	52427-382	52427-382-90	90 TABLET in 1 BOTTLE (52427-382-90)
TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Almatica Pharma LLC	52427-383	52427-383-90	90 TABLET in 1 BOTTLE (52427-383-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;25MG
Approval Date:	Jun 8, 1984	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG;25MG
Approval Date:	Jun 8, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018760

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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