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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207616


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NDA 207616 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 Speclt, 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-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-eight suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 207616
Tradename:ROSUVASTATIN CALCIUM
Applicant:Hetero Labs Ltd V
Ingredient:rosuvastatin calcium
Patents:0
Pharmacology for NDA: 207616
Medical Subject Heading (MeSH) Categories for 207616
Suppliers and Packaging for NDA: 207616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207616 ANDA Camber Pharmaceuticals, Inc. 31722-882 31722-882-31 100 TABLET, FILM COATED in 1 CARTON (31722-882-31)
ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207616 ANDA Camber Pharmaceuticals, Inc. 31722-882 31722-882-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90)

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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