Details for New Drug Application (NDA): 207375
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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 207375
Tradename: | ROSUVASTATIN CALCIUM |
Applicant: | Shandong |
Ingredient: | rosuvastatin calcium |
Patents: | 0 |
Pharmacology for NDA: 207375
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207375
Suppliers and Packaging for NDA: 207375
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 207375 | ANDA | Shandong New Time Pharmaceutical Co., Ltd. | 42677-301 | 42677-301-01 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-01) |
ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 207375 | ANDA | Shandong New Time Pharmaceutical Co., Ltd. | 42677-301 | 42677-301-02 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | May 7, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | May 7, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | May 7, 2019 | TE: | AB | RLD: | No |
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