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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079168

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NDA 079168 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Par Pharm Inc, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, and Watson Labs Inc, and is included in eighteen NDAs. It is available from thirty-five 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-five suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for 079168

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

Pharmacology for NDA: 079168

Medical Subject Heading (MeSH) Categories for 079168

Suppliers and Packaging for NDA: 079168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079168 ANDA AvKARE, Inc. 42291-742 42291-742-90 90 TABLET in 1 BOTTLE (42291-742-90)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079168 ANDA AvKARE, Inc. 42291-743 42291-743-90 90 TABLET in 1 BOTTLE (42291-743-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 19, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Oct 29, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 19, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Oct 29, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 19, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Oct 29, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE


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Serving leading biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
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Queensland Health
QuintilesIMS
Boehringer Ingelheim
AstraZeneca
Teva
Moodys
UBS

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