Application Nr Approved Date Route Status External Links
ANDA201619 2016-10-31 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: 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. Pediatric Use Information For Patients 7 To 17 Years Of Age 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 Apob 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 (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

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

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