BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Citi
Argus Health
US Department of Justice
Teva
Boehringer Ingelheim
Queensland Health
Merck
UBS
Daiichi Sankyo
Chubb

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079161

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NDA 079161 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Par Pharm Inc, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, and Watson Labs Inc, and is included in eighteen NDAs. It is available from thirty-six suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are thirty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 079161
Tradename:ROSUVASTATIN CALCIUM
Applicant:Mylan Pharms Inc
Ingredient:rosuvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079161
Medical Subject Heading (MeSH) Categories for 079161
Suppliers and Packaging for NDA: 079161
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079161 ANDA Mylan Pharmaceuticals Inc. 0378-2201 0378-2201-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2201-77)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079161 ANDA Mylan Pharmaceuticals Inc. 0378-2203 0378-2203-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2203-77)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 19, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 19, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Covington
Johnson and Johnson
Chubb
Fuji
Julphar
McKesson
Healthtrust
Colorcon
Boehringer Ingelheim

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