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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Harvard Business School
Johnson and Johnson
Queensland Health
Express Scripts

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091226

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NDA 091226 describes ATORVASTATIN CALCIUM, which is a drug marketed by 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 eleven NDAs. It is available from fifty-five 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-three suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 091226
Applicant:Mylan Pharms Inc
Ingredient:atorvastatin calcium
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091226
Medical Subject Heading (MeSH) Categories for 091226
Suppliers and Packaging for NDA: 091226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091226 ANDA Mylan Pharmaceuticals Inc. 0378-3950 N 0378-3950-77
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091226 ANDA Mylan Pharmaceuticals Inc. 0378-3950 N 0378-3950-05

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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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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