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Covington
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091650

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NDA 091650 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-one 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. Fifty-five suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 091650
Tradename:ATORVASTATIN CALCIUM
Applicant:Dr Reddys Labs Ltd
Ingredient:atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091650
Medical Subject Heading (MeSH) Categories for 091650
Suppliers and Packaging for NDA: 091650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091650 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7769 N 0615-7769-39
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091650 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7769 N 0615-7769-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 17, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 17, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Jul 17, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
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