Details for New Drug Application (NDA): 201619
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NDA 201619 describes ROSUVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd V, Inventia, Lupin, Macleods Pharms Ltd, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in twenty-eight NDAs. It is available from forty-nine suppliers. Additional details are available on the ROSUVASTATIN CALCIUM profile page.
The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 201619
| Tradename: | ROSUVASTATIN CALCIUM |
| Applicant: | Torrent |
| Ingredient: | rosuvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 201619
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 201619
Suppliers and Packaging for NDA: 201619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 201619 | ANDA | Major Pharmaceuticals | 0904-6778 | 0904-6778-61 | 100 BLISTER PACK in 1 CARTON (0904-6778-61) / 1 TABLET, COATED in 1 BLISTER PACK |
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 201619 | ANDA | Major Pharmaceuticals | 0904-6779 | 0904-6779-61 | 100 BLISTER PACK in 1 CARTON (0904-6779-61) / 1 TABLET, COATED in 1 BLISTER PACK |
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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