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Details for New Drug Application (NDA): 074265

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NDA 074265 describes ATENOLOL, which is a drug marketed by Zydus Pharms Usa, Pliva, Alvogen Malta, Able, Sun Pharm Inds Inc, Aurobindo Pharma, Teva, Apothecon, Teva Pharms, Sandoz, Mylan, Nostrum Labs, Dava Pharms Inc, Unique Pharm Labs, Watson Labs, Northstar Hlthcare, Sun Pharm Inds, SCS, Ipca Labs Ltd, and Mutual Pharm, and is included in forty-one NDAs. It is available from fifty-six 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. Sixteen suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.

Summary for NDA: 074265

Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Feb 28, 1994TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Feb 28, 1994TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Feb 28, 1994TE:RLD:No

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