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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090548

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NDA 090548 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-three 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-one suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for 090548

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090548

Medical Subject Heading (MeSH) Categories for 090548

Suppliers and Packaging for NDA: 090548

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 090548 ANDA Liberty Pharmaceuticals, Inc. 0440-7128 0440-7128-60 60 TABLET, FILM COATED in 1 BOTTLE (0440-7128-60)
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 090548 ANDA Liberty Pharmaceuticals, Inc. 0440-7128 0440-7128-81 300 TABLET, FILM COATED in 1 BOTTLE (0440-7128-81)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:May 29, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 29, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:May 29, 2012TE:ABRLD:No


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