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Details for New Drug Application (NDA): 079171

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NDA 079171 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-five 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-eight 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: 079171

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079171

Suppliers and Packaging for NDA: 079171

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rosuvastatin calcium
TABLET;ORAL 079171 ANDA Sandoz Inc 0781-5400 0781-5400-92 90 TABLET, FILM COATED in 1 BOTTLE (0781-5400-92)
rosuvastatin calcium
TABLET;ORAL 079171 ANDA Sandoz Inc 0781-5401 0781-5401-92 90 TABLET, FILM COATED in 1 BOTTLE (0781-5401-92)

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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