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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202357

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NDA 202357 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 202357
Applicant:Dr Reddys Labs Ltd
Ingredient:atorvastatin calcium
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202357
Medical Subject Heading (MeSH) Categories for 202357
Suppliers and Packaging for NDA: 202357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 202357 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7772 N 0615-7772-39
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 202357 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7772 N 0615-7772-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 80MG BASE
Approval Date:Jul 17, 2012TE:ABRLD:No

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