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Serving leading biopharmaceutical companies globally:

Queensland Health
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McKesson
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Teva
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079172

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NDA 079172 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 079172
Tradename:ROSUVASTATIN CALCIUM
Applicant:Glenmark Pharms
Ingredient:rosuvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079172
Medical Subject Heading (MeSH) Categories for 079172
Suppliers and Packaging for NDA: 079172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079172 ANDA Glenmark Pharmaceutials Inc., USA 68462-261 68462-261-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079172 ANDA Glenmark Pharmaceutials Inc., USA 68462-261 68462-261-50 50 TABLET, FILM COATED in 1 BOTTLE (68462-261-50)

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:

Farmers Insurance
Express Scripts
Novartis
Colorcon
Healthtrust
Mallinckrodt
Fish and Richardson
AstraZeneca
Deloitte

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