Details for New Drug Application (NDA): 079169
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NDA 079169 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, Mankind Pharma, 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-nine NDAs. It is available from forty-six 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. Forty-seven 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. Forty-seven suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 079169
| Tradename: | ROSUVASTATIN CALCIUM |
| Applicant: | Sun Pharm |
| Ingredient: | rosuvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 079169
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079169
Suppliers and Packaging for NDA: 079169
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 079169 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-582 | 47335-582-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-582-18) |
| ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 079169 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-582 | 47335-582-81 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-582-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 19, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 19, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 19, 2016 | TE: | RLD: | No | |||||
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