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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Express Scripts

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079168

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NDA 079168 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, Msn Labs Pvt 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 nineteen NDAs. It is available from thirty-seven 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-six suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 079168
Applicant:Par Pharm Inc
Ingredient:rosuvastatin calcium
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079168
Medical Subject Heading (MeSH) Categories for 079168
Suppliers and Packaging for NDA: 079168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079168 ANDA AvKARE, Inc. 42291-742 N 42291-742-90
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079168 ANDA AvKARE, Inc. 42291-743 N 42291-743-90

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 hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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