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Generated: November 21, 2018

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Details for New Drug Application (NDA): 018760

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NDA 018760 describes TENORETIC 50, which is a drug marketed by Alvogen Malta 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:Alvogen Malta
Ingredient:atenolol; chlorthalidone
Patents:0
Pharmacology for NDA: 018760
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased 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 Inc. 52427-382 52427-382-90 90 TABLET in 1 BOTTLE (52427-382-90)
TENORETIC 100 atenolol; chlorthalidone TABLET;ORAL 018760 NDA Almatica Pharma Inc. 52427-383 52427-383-90 90 TABLET in 1 BOTTLE (52427-383-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;25MG
Approval Date:Jun 8, 1984TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;25MG
Approval Date:Jun 8, 1984TE:ABRLD:Yes

Expired US Patents for NDA 018760

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta TENORETIC 100 atenolol; chlorthalidone TABLET;ORAL 018760-001 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta TENORETIC 50 atenolol; chlorthalidone TABLET;ORAL 018760-002 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta TENORETIC 50 atenolol; chlorthalidone TABLET;ORAL 018760-002 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta TENORETIC 50 atenolol; chlorthalidone TABLET;ORAL 018760-002 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta TENORETIC 100 atenolol; chlorthalidone TABLET;ORAL 018760-001 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta TENORETIC 100 atenolol; chlorthalidone TABLET;ORAL 018760-001 Jun 8, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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