Details for New Drug Application (NDA): 202293
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NDA 202293 describes FARXIGA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from three suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FARXIGA profile page.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for 202293
| Tradename: | FARXIGA |
| Applicant: | Astrazeneca Ab |
| Ingredient: | dapagliflozin |
| Patents: | 16 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202293
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 202293
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FARXIGA | dapagliflozin | TABLET;ORAL | 202293 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6205 | 0310-6205-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30) |
| FARXIGA | dapagliflozin | TABLET;ORAL | 202293 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6205 | 0310-6205-95 | 1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 22, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT | ||||||||
| Regulatory Exclusivity Expiration: | May 5, 2023 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION | ||||||||
| Regulatory Exclusivity Expiration: | Oct 18, 2022 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS | ||||||||
Expired US Patents for NDA 202293
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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