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Serving leading biopharmaceutical companies globally:

Julphar
Medtronic
Baxter
AstraZeneca
US Army
Farmers Insurance
Novartis
Accenture
Healthtrust
Cerilliant

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091624

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NDA 091624 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-four 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-two suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 091624
Tradename:ATORVASTATIN CALCIUM
Applicant:Kremers Urban Pharms
Ingredient:atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091624
Medical Subject Heading (MeSH) Categories for 091624
Suppliers and Packaging for NDA: 091624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091624 ANDA AvKARE, Inc. 42291-143 42291-143-10 1000 TABLET, FILM COATED in 1 BOTTLE (42291-143-10)
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091624 ANDA AvKARE, Inc. 42291-143 42291-143-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-143-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Citi
Moodys
Novartis
Julphar
Farmers Insurance
UBS
Cantor Fitzgerald
Healthtrust
Chubb

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