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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 two suppliers. Additional details are available on the TENORETIC 50 profile page.

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

Summary for NDA: 018760

Tradename:
TENORETIC 100
Applicant:
Alvogen Malta
Ingredient:
atenolol; chlorthalidone
Patents:0
Formulation / Manufacturing:see details

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 AstraZeneca Pharmaceuticals LP 0310-0115 0310-0115-10 100 TABLET in 1 BOTTLE (0310-0115-10)
TENORETIC 100
atenolol; chlorthalidone
TABLET;ORAL 018760 NDA AstraZeneca Pharmaceuticals LP 0310-0117 0310-0117-10 100 TABLET in 1 BOTTLE (0310-0117-10)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;25MG
Approval Date:Jun 8, 1984TE:ABRLD:No

Expired Orange Book Patents for NDA: 018760

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
TENORETIC 100
atenolol; chlorthalidone
TABLET;ORAL018760-001Jun 8, 19843,663,607► subscribe
Alvogen Malta
TENORETIC 50
atenolol; chlorthalidone
TABLET;ORAL018760-002Jun 8, 19843,836,671► subscribe
Alvogen Malta
TENORETIC 50
atenolol; chlorthalidone
TABLET;ORAL018760-002Jun 8, 19843,663,607► subscribe
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