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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078210


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NDA 078210 describes ATENOLOL, which is a drug marketed by Able, Apothecon, Aurobindo Pharma, Chartwell Rx, Hlthcare, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, SCS, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Twi Pharms, Unichem, Unique, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Aurobindo Pharma Usa, Novitium Pharma, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from thirty-two 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. Ten suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 078210
Tradename:ATENOLOL
Applicant:Sun Pharm Inds Inc
Ingredient:atenolol
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Jul 10, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jul 10, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Jul 10, 2007TE:RLD:No

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