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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

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 Changzhou Pharm, Hetero Labs Ltd V, Torrent Pharms Ltd, Accord Hlthcare, Apotex Inc, Biocon Ltd, Cadila Pharms Ltd, Mylan Pharms Inc, Jubilant Generics, Alkem Labs Ltd, Teva Pharms Usa, Watson Labs Inc, Par Pharm Inc, Sun Pharma Global, Aurobindo Pharma Ltd, Sandoz Inc, and Glenmark Pharms, and is included in seventeen NDAs. It is available from thirty-one suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for NDA: 079161

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Army
Federal Trade Commission
Cantor Fitzgerald
Farmers Insurance
Colorcon
Citi
Deloitte
Express Scripts
US Department of Justice

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