Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Dow
Johnson and Johnson
Boehringer Ingelheim
McKesson

Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207408

See Plans and Pricing

« Back to Dashboard

NDA 207408 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Allied, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Msn Labs Pvt Ltd, Mylan, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, and Zydus Pharms, and is included in twenty-four NDAs. It is available from forty-two suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty-two 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 207408
Tradename:ROSUVASTATIN CALCIUM
Applicant:Changzhou Pharm
Ingredient:rosuvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207408
Medical Subject Heading (MeSH) Categories for 207408
Suppliers and Packaging for NDA: 207408
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207408 ANDA Tris Pharma Inc 27808-155 27808-155-01 90 TABLET, FILM COATED in 1 BOTTLE (27808-155-01)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207408 ANDA Tris Pharma Inc 27808-155 27808-155-03 500 TABLET, FILM COATED in 1 BOTTLE (27808-155-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 31, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 31, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 31, 2016TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
AstraZeneca
Merck
Dow
McKinsey

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.