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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079145

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NDA 079145 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-eight suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty 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 079145
Tradename:ROSUVASTATIN CALCIUM
Applicant:Apotex Inc
Ingredient:rosuvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079145
Medical Subject Heading (MeSH) Categories for 079145
Suppliers and Packaging for NDA: 079145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079145 ANDA Apotex Corp. 60505-2885 N 60505-2885-0
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079145 ANDA Apotex Corp. 60505-2885 N 60505-2885-5

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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