QTERNMET XR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Dapagliflozin; Saxagliptin Hydrochloride; Metformin Hydrochloride.
| Product ID | 0310-6990_19500f2f-6cc0-4c18-ad84-e33206608c10 |
| NDC | 0310-6990 |
| Product Type | Human Prescription Drug |
| Proprietary Name | QTERNMET XR |
| Generic Name | Dapagliflozin Saxagliptin And Metformin Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-06-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210874 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/1; mg/1; mg/1 |
| Pharm Classes | Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA210874 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-01 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-6925 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride |
| 0310-6950 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride |
| 0310-6975 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride |
| 0310-6990 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QTERNMET 86741028 5158756 Live/Registered |
AstraZeneca AB 2015-08-28 |