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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 Changzhou Pharm, Hetero Labs Ltd V, Torrent Pharms Llc, Accord Hlthcare Inc, Apotex Inc, Biocon 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 fifteen 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-four 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: 079167

Tradename:
ROSUVASTATIN CALCIUM
Applicant:
Watson Labs Inc
Ingredient:
rosuvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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
rosuvastatin calcium
TABLET;ORAL 079167 ANDA Major Pharmaceuticals 0904-6602 0904-6602-61 100 BLISTER PACK in 1 CARTON (0904-6602-61) > 1 TABLET in 1 BLISTER PACK
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL 079167 ANDA Major Pharmaceuticals 0904-6603 0904-6603-61 100 BLISTER PACK in 1 CARTON (0904-6603-61) > 1 TABLET in 1 BLISTER PACK

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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