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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 074056


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NDA 074056 describes ATENOLOL, which is a drug marketed by Able, Apothecon, Aurobindo Pharma, Chartwell Rx, Esjay Pharma, Hlthcare, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, SCS, 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-four 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 074056
Tradename:ATENOLOL
Applicant:Teva
Ingredient:atenolol
Patents:0
Pharmacology for NDA: 074056
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 074056
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL atenolol TABLET;ORAL 074056 ANDA Teva Pharmaceuticals USA, Inc. 0093-0752 0093-0752-01 100 TABLET in 1 BOTTLE (0093-0752-01)
ATENOLOL atenolol TABLET;ORAL 074056 ANDA Teva Pharmaceuticals USA, Inc. 0093-0752 0093-0752-10 1000 TABLET in 1 BOTTLE (0093-0752-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 18, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 18, 1995TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 19, 2004TE:ABRLD:No

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