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Last Updated: October 19, 2020

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Details for New Drug Application (NDA): 078512

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NDA 078512 describes ATENOLOL, which is a drug marketed by Able, Alvogen, Apothecon, Aurobindo Pharma, Dava Pharms Inc, Hlthcare, Invatech, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, SCS, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Unichem Labs Ltd, Unique Pharm Labs, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from thirty-six 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. Eight suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 078512
Tradename:ATENOLOL
Applicant:Aurobindo Pharma
Ingredient:atenolol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078512
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 078512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL atenolol TABLET;ORAL 078512 ANDA Aurobindo Pharma Limited 65862-168 65862-168-01 100 TABLET in 1 BOTTLE (65862-168-01)
ATENOLOL atenolol TABLET;ORAL 078512 ANDA Aurobindo Pharma Limited 65862-168 65862-168-99 1000 TABLET in 1 BOTTLE (65862-168-99)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Oct 31, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 31, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 31, 2007TE:ABRLD:No

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