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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
AstraZeneca
US Department of Justice
Fuji
Teva
Mallinckrodt
Daiichi Sankyo
Harvard Business School
Express Scripts
Queensland Health

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205519

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NDA 205519 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 205519

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

Pharmacology for NDA: 205519

Medical Subject Heading (MeSH) Categories for 205519

Suppliers and Packaging for NDA: 205519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519 ANDA ScieGen Pharmaceuticals, Inc. 50228-451 50228-451-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-451-10)
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519 ANDA ScieGen Pharmaceuticals, Inc. 50228-451 50228-451-90 90 TABLET, FILM COATED in 1 BOTTLE (50228-451-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:May 19, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 19, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:May 19, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
US Department of Justice
McKinsey
Cantor Fitzgerald
Julphar
Farmers Insurance
Argus Health
Moodys
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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