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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076900

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NDA 076900 describes ATENOLOL, which is a drug marketed by Able, Alvogen, Apothecon, Aurobindo Pharma, Dava Pharms Inc, Hlthcare, 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, Zydus Pharms Usa, and Zydus Pharms, and is included in thirty-eight NDAs. It is available from forty-one suppliers. Additional details are available on the ATENOLOL profile page.

The generic ingredient in ATENOLOL is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 076900
Tradename:ATENOLOL
Applicant:Zydus Pharms Usa
Ingredient:atenolol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076900
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 076900
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL atenolol TABLET;ORAL 076900 ANDA Apotheca Inc. 12634-605 12634-605-00 10 TABLET in 1 BOTTLE (12634-605-00)
ATENOLOL atenolol TABLET;ORAL 076900 ANDA Apotheca Inc. 12634-605 12634-605-01 100 TABLET in 1 BOTTLE (12634-605-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 28, 2005TE:ABRLD:No

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