Details for New Drug Application (NDA): 207616
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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
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Oct 31, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Oct 31, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Oct 31, 2016 | TE: | AB | RLD: | No |
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