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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 018240

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NDA 018240 describes TENORMIN, which is a drug marketed by Astrazeneca and Twi Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the TENORMIN profile page.

The generic ingredient in TENORMIN is atenolol. There are thirty-four drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the atenolol profile page.

Summary for 018240

Tradename:	TENORMIN
Applicant:	Twi Pharms
Ingredient:	atenolol
Patents:	0

Pharmacology for NDA: 018240

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 018240

Adrenergic beta-1 Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 018240

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TENORMIN	atenolol	TABLET;ORAL	018240	NDA	Almatica Pharma LLC	52427-429	52427-429-90	90 TABLET in 1 BOTTLE (52427-429-90)
TENORMIN	atenolol	TABLET;ORAL	018240	NDA	Almatica Pharma LLC	52427-430	52427-430-90	90 TABLET in 1 BOTTLE (52427-430-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 9, 1990	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018240

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	⤷ Sign Up	⤷ Sign Up
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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