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Generated: June 19, 2019

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Details for New Drug Application (NDA): 018240

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NDA 018240 describes TENORMIN, which is a drug marketed by Astrazeneca and Alvogen Malta 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the atenolol profile page.
Summary for 018240
Tradename:TENORMIN
Applicant:Alvogen Malta
Ingredient:atenolol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018240
Mechanism of ActionAdrenergic beta-Antagonists
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 Inc. 52427-429 52427-429-90 90 TABLET in 1 BOTTLE (52427-429-90)
TENORMIN atenolol TABLET;ORAL 018240 NDA Almatica Pharma Inc. 52427-430 52427-430-90 90 TABLET in 1 BOTTLE (52427-430-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 9, 1990TE:ABRLD:Yes

Expired US Patents for NDA 018240

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

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