Rosuvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sciegen Pharmaceuticals, Inc.. The primary component is Rosuvastatin.
| Product ID | 50228-116_15b01faa-3e2c-48b7-a7a9-a0adfa2b0c35 |
| NDC | 50228-116 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Rosuvastatin |
| Generic Name | Rosuvastatin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-04-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206381 |
| Labeler Name | ScieGen Pharmaceuticals, Inc. |
| Substance Name | ROSUVASTATIN |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-04-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206381 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-24 |
| Marketing Category | ANDA |
| Application Number | ANDA206381 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-24 |
| Marketing Category | ANDA |
| Application Number | ANDA206381 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-24 |
| Ingredient | Strength |
|---|---|
| ROSUVASTATIN | 5 mg/1 |
| SPL SET ID: | ee4933c5-0d97-494d-ac0f-2083e0100836 |
| Manufacturer | |
| UNII | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16729-284 | Rosuvastatin | Rosuvastatin |
| 16729-285 | Rosuvastatin | Rosuvastatin |
| 16729-286 | Rosuvastatin | Rosuvastatin |
| 16729-287 | Rosuvastatin | Rosuvastatin |
| 31722-882 | Rosuvastatin | Rosuvastatin |
| 31722-883 | Rosuvastatin | Rosuvastatin |
| 31722-884 | Rosuvastatin | Rosuvastatin |
| 31722-885 | Rosuvastatin | Rosuvastatin |
| 49252-061 | ROSUVASTATIN | rosuvastatin |
| 49252-062 | ROSUVASTATIN | rosuvastatin |
| 49252-063 | ROSUVASTATIN | rosuvastatin |
| 49252-064 | ROSUVASTATIN | rosuvastatin |
| 50090-2722 | Rosuvastatin | Rosuvastatin |
| 50090-2723 | Rosuvastatin | Rosuvastatin |
| 69238-1148 | Rosuvastatin | Rosuvastatin |
| 69238-1146 | Rosuvastatin | Rosuvastatin |
| 69238-1147 | Rosuvastatin | Rosuvastatin |
| 69238-1149 | Rosuvastatin | Rosuvastatin |
| 70518-0986 | Rosuvastatin | Rosuvastatin |
| 70518-1219 | Rosuvastatin | Rosuvastatin |
| 70518-1601 | Rosuvastatin | Rosuvastatin |
| 70518-1384 | Rosuvastatin | Rosuvastatin |
| 71205-044 | Rosuvastatin | Rosuvastatin |
| 50090-2724 | Rosuvastatin | Rosuvastatin |
| 50090-2725 | Rosuvastatin | Rosuvastatin |
| 50268-711 | Rosuvastatin | Rosuvastatin |
| 50268-709 | Rosuvastatin | Rosuvastatin |
| 50268-710 | Rosuvastatin | Rosuvastatin |
| 55700-574 | Rosuvastatin | Rosuvastatin |
| 55700-575 | Rosuvastatin | Rosuvastatin |
| 60505-2886 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-2885 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-2888 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-2887 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN |
| 61919-786 | Rosuvastatin | Rosuvastatin |
| 50228-116 | Rosuvastatin | Rosuvastatin |
| 50228-117 | Rosuvastatin | Rosuvastatin |
| 50228-119 | Rosuvastatin | Rosuvastatin |
| 50228-118 | Rosuvastatin | Rosuvastatin |
| 47335-984 | EZALLOR SPRINKLE | ROSUVASTATIN |
| 47335-985 | EZALLOR SPRINKLE | ROSUVASTATIN |
| 47335-986 | EZALLOR SPRINKLE | ROSUVASTATIN |
| 47335-987 | EZALLOR SPRINKLE | ROSUVASTATIN |