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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090548

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NDA 090548 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Invagen Pharms, Lannett Co Inc, Mylan Pharms Inc, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fifty-eight suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.

The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 090548
Tradename:ATORVASTATIN CALCIUM
Applicant:Apotex Inc
Ingredient:atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090548
Medical Subject Heading (MeSH) Categories for 090548
Suppliers and Packaging for NDA: 090548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 090548 ANDA Liberty Pharmaceuticals, Inc. 0440-7128 N 0440-7128-30
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 090548 ANDA Liberty Pharmaceuticals, Inc. 0440-7128 N 0440-7128-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:May 29, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 29, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:May 29, 2012TE:ABRLD:No

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Farmers Insurance
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Cantor Fitzgerald
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