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Serving leading biopharmaceutical companies globally:

Covington
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Fuji
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Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079170

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NDA 079170 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, Glenmark Pharms, and Lupin Ltd, and is included in eighteen NDAs. It is available from thirty-four suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

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

Summary for NDA: 079170

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079170

Suppliers and Packaging for NDA: 079170

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL 079170 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-332 43353-332-15 15 TABLET in 1 BOTTLE (43353-332-15)
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL 079170 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-332 43353-332-17 6030 TABLET in 1 BOTTLE (43353-332-17)

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 leading biopharmaceutical companies globally:

Express Scripts
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