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Generated: September 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206434

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NDA 206434 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Allied, 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 Pharms Ltd, and Watson Labs Inc, and is included in nineteen NDAs. It is available from thirty-eight suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty-one 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 206434
Tradename:ROSUVASTATIN CALCIUM
Applicant:Accord Hlthcare
Ingredient:rosuvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206434
Medical Subject Heading (MeSH) Categories for 206434
Suppliers and Packaging for NDA: 206434
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206434 ANDA Accord Healthcare Inc. 16729-284 16729-284-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-284-15)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206434 ANDA Accord Healthcare Inc. 16729-284 16729-284-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-284-17)

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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