dapagliflozin Oral Tablet
- Brand(s)
- Farxiga
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Astrazeneca Pharmaceuticals Lp (2015-03-12)
- Oldest Current Product
- 2014-01-08
- License(s)
- NDA
- RxNORM
- ORAL TABLET\DAPAGLIFLOZIN
- FDAOB
- ORAL\TABLET\DAPAGLIFLOZIN PROPANEDIOL
- SPL Active
- ORAL\TABLET, FILM COATED\DAPAGLIFLOZIN PROPANEDIOL
- SPL Moiety
- ORAL\TABLET, FILM COATED\DAPAGLIFLOZIN
product(s) by strength(s)
dapagliflozin 10 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000031428 | Farxiga | NDA | E.R. Squibb & Sons, L.L.C. | 2014-01-08 | 2017-08-31 | DAPAGLIFLOZIN PROPANEDIOL | ORAL | TABLET, FILM COATED | NDA202293 | fc6ae30e-868b-4ac9-b69d-900922503998 |
dapagliflozin 5 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003106205 | Farxiga | NDA | Astrazeneca Pharmaceuticals Lp | 2015-01-05 | DAPAGLIFLOZIN PROPANEDIOL | ORAL | TABLET, FILM COATED | NDA202293 | 72ad22ae-efe6-4cd6-a302-98aaee423d69 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA202293 | FARXIGA | ASTRAZENECA AB | 2014-01-08 | p6414126, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE p8501698, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE p8361972, TREATMENT OF TYPE 2 DIABETES MELLITUS p7919598 p7851502, SUBSTANCE p8685934, TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT p6515117, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE p6936590, TREATMENT OF TYPE 2 DIABETES MELLITUS p8716251, SUBSTANCE p8221786, SUBSTANCE | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLITFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA [2018-03-11] NEW CHEMICAL ENTITY [2019-01-08] | NDA202293_001, NDA202293_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA202293_001 | RX | DAPAGLIFLOZIN PROPANEDIOL (EQ 5MG BASE) | ORAL | TABLET | False | 2014-01-08 | FARXIGA |
| 2 | NDA202293_002 | RX | DAPAGLIFLOZIN PROPANEDIOL (EQ 10MG BASE) | ORAL | TABLET | True | 2014-01-08 | FARXIGA |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6414126 (view patent) | 2020-10-04 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 2 | p6515117 (view patent) | 2020-10-04 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 3 | p6936590 (view patent) | 2020-10-04 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 4 | p7851502 (view patent) | 2028-08-19 | NDA202293 | |
| 5 | p7919598 (view patent) | 2029-12-16 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 6 | p8221786 (view patent) | 2028-03-21 | NDA202293 | |
| 7 | p8361972 (view patent) | 2028-03-21 | NDA202293 | |
| 8 | p8501698 (view patent) | 2027-06-20 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 9 | p8685934 (view patent) | 2030-05-26 | NDA202293, NDA205649 | dapagliflozin / Metformin Extended Release Oral Tablet |
| 10 | p8716251 (view patent) | 2028-03-21 | NDA202293 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 72ad22ae-efe6-4cd6-a302-98aaee423d69 (view SPL) | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014 | prescription | Human Prescription | Astrazeneca Pharmaceuticals Lp | 2015-03-12 | 3 | 003106205, 003106210 |
| 2 | fc6ae30e-868b-4ac9-b69d-900922503998 (view SPL) | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014 | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2014-08-11 | 3 | 000031428, 000031427 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII