Application Nr Approved Date Route Status External Links
ANDA079167 2016-04-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Rosuvastatin Calcium Tablets Are An Hmg Co-A Reductase Inhibitor Indicated For: Pediatric Patients 7 To 17 Years Of Age With Homozygous Familial Hypercholesterolemia (hofh) To Reduce Ldl-C, Total-C, Non-Hdl-C And Apo-B As An Adjunct To Diet, Either Alone Or With Other Lipid-Lowering Treatments (1.2) Adult Patients With Hypertriglyceridemia As An Adjunct To Diet (1.3) Adult Patients With Primary Dysbetalipoproteinemia (type Iii Hyperlipoproteinemia) As An Adjunct To Diet (1.4) Adult Patients With Homozygous Familial Hypercholesterolemia (hofh) To Reduce Ldl-C, Total-C, And Apob (1.5) Limitations Of Use (1.8): Rosuvastatin Calcium Tablets Have Not Been Studied In Fredrickson Type I And V Dyslipidemias. 1.2 Pediatric Patients With Familial Hypercholesterolemia Rosuvastatin Calcium Tablets Are Indicated As An Adjunct To Diet To: ● Reduce Ldl-C, Total-C, Non-Hdl-C And Apo-B In Children And Adolescents 7 To 17 Years Of Age With Homozygous Familial Hypercholesterolemia, Either Alone Or With Other Lipid-Lowering Treatments (e.g., Ldl Apheresis). Pediatric Use Information For Patients Ages 8 To Less Than 10 Years Is Approved For Astrazeneca’s Crestor (rosuvastatin Calcium) Tablets. However, Due To Astrazeneca’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. 1. 3 Hypertriglyceridemia Rosuvastatin Calcium Tablets Are Indicated As Adjunctive Therapy To Diet For The Treatment Of Adult Patients With Hypertriglyceridemia. 1. 4 Primary Dysbetalipoproteinemia (type Iii Hyperlipoproteinemia) Rosuvastatin Calcium Tablets Are Indicated As An Adjunct To Diet For The Treatment Of Adult Patients With Primary Dysbetalipoproteinemia (type Iii Hyperlipoproteinemia). 1. 5 Adult Patients With Homozygous Familial Hypercholesterolemia Rosuvastatin Calcium Tablets Are Indicated As Adjunctive Therapy To Other Lipid-Lowering Treatments (e.g., Ldl Apheresis) Or Alone If Such Treatments Are Unavailable To Reduce Ldl-C, Total-C, And Apo-B In Adult Patients With Homozygous Familial Hypercholesterolemia. 1. 8 Limitations Of Use Rosuvastatin Calcium Tablets Have Not Been Studied In Fredrickson Type I And V Dyslipidemias.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Sodium Carbonate Monohydrate SODIUM CARBONATE MONOHYDRATE Unresolved
3. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rosuvastatin Calcium ROSUVASTATIN CALCIUM ZINC1535101

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