Dapagliflozin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Dapagliflozin.
| Product ID | 70748-106_b2ba541f-f831-499b-9161-c54ae831900c |
| NDC | 70748-106 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dapagliflozin |
| Generic Name | Dapagliflozin |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-11-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211531 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | DAPAGLIFLOZIN |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-11-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211531 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-11-15 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA211531 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-11-15 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA211531 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-11-15 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA211531 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-11-15 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| DAPAGLIFLOZIN | 10 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70748-106 | Dapagliflozin | Dapagliflozin |
| 70748-105 | Dapagliflozin | Dapagliflozin |
| 0310-6205 | FARXIGA | DAPAGLIFLOZIN |
| 0310-6210 | FARXIGA | DAPAGLIFLOZIN |
| 50090-3481 | FARXIGA | DAPAGLIFLOZIN |
| 50090-3482 | FARXIGA | DAPAGLIFLOZIN |
| 55154-6932 | FARXIGA | DAPAGLIFLOZIN |