Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Covington
Deloitte
Novartis
McKinsey
Johnson and Johnson
UBS
AstraZeneca
Julphar
Healthtrust

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079172

« Back to Dashboard
NDA 079172 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: 079172

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

Pharmacology for NDA: 079172

Suppliers and Packaging for NDA: 079172

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL 079172 ANDA Glenmark Pharmaceutials Inc., USA 68462-261 68462-261-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-261-01)
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL 079172 ANDA Glenmark Pharmaceutials Inc., USA 68462-261 68462-261-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10)

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
AstraZeneca
Federal Trade Commission
Daiichi Sankyo
Medtronic
Moodys
Chinese Patent Office
Express Scripts
Chubb
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot