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Details for New Drug Application (NDA): 079167

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NDA 079167 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Apotex Inc, Mylan Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Par Pharm Inc, Sun Pharma Global, Aurobindo Pharma Ltd, Sandoz Inc, and Glenmark Pharms, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are thirty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for NDA: 079167

Watson Labs Inc
rosuvastatin calcium
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 079167

Suppliers and Packaging for NDA: 079167

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rosuvastatin calcium
TABLET;ORAL 079167 ANDA Actavis Pharma, Inc. 16252-615 16252-615-30 1 BOTTLE in 1 CARTON (16252-615-30) > 30 TABLET in 1 BOTTLE
rosuvastatin calcium
TABLET;ORAL 079167 ANDA Actavis Pharma, Inc. 16252-615 16252-615-50 1 BOTTLE in 1 CARTON (16252-615-50) > 500 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 29, 2016TE:ABRLD:No

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