Details for New Drug Application (NDA): 079170
✉ Email this page to a colleague
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 079170
Tradename: | ROSUVASTATIN CALCIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | rosuvastatin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079170
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079170
Suppliers and Packaging for NDA: 079170
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 079170 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-332 | 43353-332-15 | 15 TABLET in 1 BOTTLE (43353-332-15) |
ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 079170 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-332 | 43353-332-17 | 6030 TABLET in 1 BOTTLE (43353-332-17) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jul 19, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription