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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207408

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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 Pharms Inc, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, Torrent, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in twenty-one 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-nine 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 27808-156 27808-156-01 90 TABLET, FILM COATED in 1 BOTTLE (27808-156-01)

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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