➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Mallinckrodt
Colorcon
Express Scripts
Moodys

Last Updated: August 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207752

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 207752 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, Mylan, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Zhejiang Yongtai, and Zydus Pharms, and is included in twenty-six NDAs. It is available from forty 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-two suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 207752
Tradename:ROSUVASTATIN CALCIUM
Applicant:Biocon Ltd
Ingredient:rosuvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207752
Medical Subject Heading (MeSH) Categories for 207752
Suppliers and Packaging for NDA: 207752
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207752 ANDA Biocon Pharma Inc 70377-006 70377-006-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-11)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207752 ANDA Biocon Pharma Inc 70377-006 70377-006-12 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-12)

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:

Harvard Business School
AstraZeneca
McKesson
Johnson and Johnson
Express Scripts
Merck

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 verification 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.