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Serving leading biopharmaceutical companies globally:

Moodys
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073457

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NDA 073457 describes ATENOLOL, which is a drug marketed by Able, Alvogen Malta, Apothecon, Aurobindo Pharma, Dava Pharms Inc, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, Sandoz, SCS, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Unique Pharm Labs, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, and Mutual Pharm, and is included in forty-one NDAs. It is available from fifty-nine 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 073457
Tradename:ATENOLOL
Applicant:Mylan
Ingredient:atenolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073457
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 073457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATENOLOL atenolol TABLET;ORAL 073457 ANDA Mylan Pharmaceuticals Inc. 0378-0218 0378-0218-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01)
ATENOLOL atenolol TABLET;ORAL 073457 ANDA Mylan Pharmaceuticals Inc. 0378-0218 0378-0218-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 24, 1992TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 26, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 24, 1992TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
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Fish and Richardson
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Argus Health
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Healthtrust
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