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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077443

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NDA 077443 describes ATENOLOL, which is a drug marketed by Able, Alvogen Malta, Apothecon, Aurobindo Pharma, Dava Pharms Inc, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, Sandoz, SCS, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Unique Pharm Labs, Watson Labs, Watson Labs Teva, and Zydus Pharms Usa, and is included in forty NDAs. It is available from fifty-eight suppliers. Additional details are available on the ATENOLOL profile page.

The generic ingredient in ATENOLOL is atenolol; chlorthalidone. There are thirty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 077443
Tradename:ATENOLOL
Applicant:Unique Pharm Labs
Ingredient:atenolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077443
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 077443
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL atenolol TABLET;ORAL 077443 ANDA Blenheim Pharmacal, Inc. 10544-167 E 10544-167-30
ATENOLOL atenolol TABLET;ORAL 077443 ANDA Blenheim Pharmacal, Inc. 10544-167 E 10544-167-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 13, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 13, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 13, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Harvard Business School
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