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Last Updated: March 28, 2024

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, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd V, Inventia, Lupin, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in twenty-seven NDAs. It is available from forty-three 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-four 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;ORALStrengthEQ 5MG BASE
Approval Date:Oct 31, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 31, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 31, 2016TE:ABRLD:No

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