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Details for New Drug Application (NDA): 202357

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NDA 202357 describes ATORVASTATIN CALCIUM, which is a drug marketed by Sciegen Pharms Inc, Kremers Urban Pharms, Mylan Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Teva Pharms, Sandoz Inc, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from forty-five suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.

The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty 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 NDA: 202357

Tradename:
ATORVASTATIN CALCIUM
Applicant:
Dr Reddys Labs Ltd
Ingredient:
atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 0615-7772-05 15 TABLET in 1 BLISTER PACK (0615-7772-05)
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL 202357 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7772 0615-7772-39 30 TABLET in 1 BLISTER PACK (0615-7772-39)

Summary for product number 001

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


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