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Last Updated: January 18, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207752

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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 Labs Pvt Ltd, Mylan, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Zhejiang Yongtai, and Zydus Pharms, and is included in twenty-five NDAs. It is available from thirty-seven 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 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

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