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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213302


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NDA 213302 describes ATENOLOL AND CHLORTHALIDONE, which is a drug marketed by Aurobindo Pharma Usa, Nostrum Labs, Novitium Pharma, Pliva, Sun Pharm Industries, Twi Pharms, Unichem, Watson Labs, and Zydus Pharms, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the ATENOLOL AND CHLORTHALIDONE profile page.

The generic ingredient in ATENOLOL AND CHLORTHALIDONE 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 213302
Tradename:ATENOLOL AND CHLORTHALIDONE
Applicant:Unichem
Ingredient:atenolol; chlorthalidone
Patents:0
Pharmacology for NDA: 213302
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 213302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 213302 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-400 29300-400-01 100 TABLET in 1 BOTTLE (29300-400-01)
ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 213302 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-400 29300-400-05 500 TABLET in 1 BOTTLE (29300-400-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;25MG
Approval Date:Nov 25, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;25MG
Approval Date:Nov 25, 2020TE:ABRLD:No

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