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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205519

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NDA 205519 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Invagen Pharms, Kremers Urban Pharms, 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-seven 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-four suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 205519
Tradename:ATORVASTATIN CALCIUM
Applicant:Sciegen Pharms Inc
Ingredient:atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205519
Medical Subject Heading (MeSH) Categories for 205519
Suppliers and Packaging for NDA: 205519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519 ANDA Marlex Pharmaceuticals Inc 10135-649 N 10135-649-10
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519 ANDA Marlex Pharmaceuticals Inc 10135-650 N 10135-650-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:May 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 19, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:May 19, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
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