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Details for New Drug Application (NDA): 079166

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NDA 079166 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Changzhou Pharm, Hetero Labs Ltd V, Torrent Pharms Llc, Accord Hlthcare Inc, Apotex Inc, Biocon Ltd, Cadila Pharms Ltd, Mylan Pharms Inc, Jubilant Generics, Teva Pharms Usa, Watson Labs Inc, Par Pharm Inc, Sun Pharma Global, Aurobindo Pharma Ltd, Sandoz Inc, and Glenmark Pharms, and is included in sixteen NDAs. It is available from twenty-four suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are thirty-seven drug master file entries for this compound. Thirty-seven 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: 079166

Teva Pharms Usa
rosuvastatin calcium
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079166

Suppliers and Packaging for NDA: 079166

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rosuvastatin calcium
TABLET;ORAL 079166 ANDA Teva Pharmaceuticals USA, Inc. 0093-7570 0093-7570-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7570-98)
rosuvastatin calcium
TABLET;ORAL 079166 ANDA Teva Pharmaceuticals USA, Inc. 0093-7571 0093-7571-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7571-98)

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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