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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208850

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NDA 208850 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 208850
Tradename:ROSUVASTATIN CALCIUM
Applicant:Amneal Pharms Co
Ingredient:rosuvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208850
Medical Subject Heading (MeSH) Categories for 208850
Suppliers and Packaging for NDA: 208850
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850 ANDA Amneal Pharmaceuticals NY LLC 69238-1146 69238-1146-9 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850 ANDA Amneal Pharmaceuticals NY LLC 69238-1147 69238-1147-9 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1147-9)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Oct 16, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Oct 16, 2018TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Oct 16, 2018TE:RLD:No

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