Details for New Drug Application (NDA): 208850
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NDA 208850 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 208850
| Tradename: | ROSUVASTATIN CALCIUM |
| Applicant: | Amneal Pharms Co |
| Ingredient: | rosuvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 208850
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208850
Suppliers and Packaging for NDA: 208850
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 208850 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1146 | 69238-1146-9 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9) |
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 208850 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1147 | 69238-1147-9 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1147-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Oct 16, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 16, 2018 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 16, 2018 | TE: | RLD: | No | |||||
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