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Serving leading biopharmaceutical companies globally:

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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079169

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NDA 079169 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 079169
Tradename:ROSUVASTATIN CALCIUM
Applicant:Sun Pharma Global
Ingredient:rosuvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079169
Medical Subject Heading (MeSH) Categories for 079169
Suppliers and Packaging for NDA: 079169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079169 ANDA Sun Pharma Global FZE 47335-582 47335-582-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-582-08)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079169 ANDA Sun Pharma Global FZE 47335-582 47335-582-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-582-18)

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:

Johnson and Johnson
Cipla
UBS
Harvard Business School
Julphar
McKinsey
Argus Health
Moodys
AstraZeneca

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