Application 205649
- Type
- NDA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;500MG | Yes | No |
| 002 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM | Yes | No |
| 003 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;500MG | Yes | No |
| 004 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;1GM | Yes | Yes |
| 005 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;1GM | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205649-001 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 |
| N205649-002 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 |
| N205649-003 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;500MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 |
| N205649-004 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-10-29 |
| N205649-005 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-07-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N205649-001 | AB |
| N205649-002 | AB |
| N205649-003 | AB |
| N205649-004 | AB |
| N205649-005 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205649-001 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 |
| N205649-001 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N205649-001 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 |
| N205649-001 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N205649-001 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | |
| N205649-001 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | |
| N205649-001 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N205649-001 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | |
| N205649-001 | 8685934*PED | 2030-11-26 | Pediatric extension | ||
| N205649-001 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N205649-002 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 |
| N205649-002 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N205649-002 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 |
| N205649-002 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N205649-002 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | |
| N205649-002 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | |
| N205649-002 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N205649-002 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | |
| N205649-002 | 8685934*PED | 2030-11-26 | Pediatric extension | ||
| N205649-002 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N205649-003 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 |
| N205649-003 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N205649-003 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 |
| N205649-003 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N205649-003 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | |
| N205649-003 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | |
| N205649-003 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N205649-003 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | |
| N205649-003 | 8685934*PED | 2030-11-26 | Pediatric extension | ||
| N205649-003 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N205649-004 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 |
| N205649-004 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N205649-004 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 |
| N205649-004 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N205649-004 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | |
| N205649-004 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | |
| N205649-004 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N205649-004 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | |
| N205649-004 | 8685934*PED | 2030-11-26 | Pediatric extension | ||
| N205649-004 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N205649-005 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 |
| N205649-005 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N205649-005 | 8501698 | 2027-06-20 | U-493 | Drug product | 2017-08-30 |
| N205649-005 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N205649-005 | 7919598 | 2029-12-16 | Drug substance | 2017-08-30 | |
| N205649-005 | 8685934 | 2030-05-26 | U-1522 | 2017-08-30 | |
| N205649-005 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N205649-005 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | |
| N205649-005 | 8685934*PED | 2030-11-26 | Pediatric extension | ||
| N205649-005 | 9616028*PED | 2031-05-12 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N205649-001 | NPP | 2027-06-12 |
| N205649-001 | PED | 2027-12-12 |
| N205649-002 | NPP | 2027-06-12 |
| N205649-002 | PED | 2027-12-12 |
| N205649-003 | NPP | 2027-06-12 |
| N205649-003 | PED | 2027-12-12 |
| N205649-004 | NPP | 2027-06-12 |
| N205649-004 | PED | 2027-12-12 |
| N205649-005 | NPP | 2027-06-12 |
| N205649-005 | PED | 2027-12-12 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | XIGDUO XR | 5MG;500MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | XIGDUO XR | 5MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | XIGDUO XR | 10MG;500MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-10-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | XIGDUO XR | 10MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-10-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-005 | XIGDUO XR | 2.5MG;1GM | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-07-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-005 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 6515117*PED | 2026-04-04 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 8501698*PED | 2027-12-20 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 7919598*PED | 2030-06-16 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 8685934*PED | 2030-11-26 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | 9616028*PED | 2031-05-12 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 6515117*PED | 2026-04-04 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 8501698*PED | 2027-12-20 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 7919598*PED | 2030-06-16 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 8685934*PED | 2030-11-26 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | 9616028*PED | 2031-05-12 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 6515117*PED | 2026-04-04 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 8501698*PED | 2027-12-20 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 7919598*PED | 2030-06-16 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 8685934*PED | 2030-11-26 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | 9616028*PED | 2031-05-12 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 6515117*PED | 2026-04-04 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 8501698 | 2027-06-20 | U-493 | Drug product | 2014-11-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 8501698*PED | 2027-12-20 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 7919598 | 2029-12-16 | Drug substance | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 8685934 | 2030-05-26 | U-1522 | 2014-11-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 7919598*PED | 2030-06-16 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 9616028 | 2030-11-12 | Drug product | 2017-08-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 8685934*PED | 2030-11-26 | Pediatric extension | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | 9616028*PED | 2031-05-12 | Pediatric extension | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | NPP | 2027-06-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-001 | PED | 2027-12-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | NPP | 2027-06-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-002 | PED | 2027-12-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | NPP | 2027-06-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-003 | PED | 2027-12-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | NPP | 2027-06-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-004 | PED | 2027-12-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-005 | NPP | 2027-06-12 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N205649-005 | PED | 2027-12-12 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| dapagliflozin and metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Prasco Laboratories | eaf135b6-e378-4f62-a1e7-db45e23668c7 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 205649 NDA205649 |
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 205649 NDA205649 0310-6260 0310-6225 0310-6270 0310-6250 0310-6280 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6225 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6250 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6260 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6270 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6280 | XIGDUO | dapagliflozin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80707 | SUPPL | 2024-12-26 |
| 80700 | SUPPL | 2024-12-23 |
| 80699 | SUPPL | 2024-12-23 |
| 78791 | SUPPL | 2024-06-13 |
| 78790 | SUPPL | 2024-06-13 |
| 75426 | SUPPL | 2023-09-13 |
| 75413 | SUPPL | 2023-09-13 |
| 72372 | SUPPL | 2022-10-17 |
| 72371 | SUPPL | 2022-10-17 |
| 72328 | SUPPL | 2022-10-14 |
| 70761 | SUPPL | 2022-04-14 |
| 70760 | SUPPL | 2022-04-14 |
| 70752 | SUPPL | 2022-04-12 |
| 70102 | SUPPL | 2022-02-07 |
| 70101 | SUPPL | 2022-02-07 |
| 70092 | SUPPL | 2022-02-04 |
| 61775 | SUPPL | 2020-02-04 |
| 61772 | SUPPL | 2020-02-04 |
| 61771 | SUPPL | 2020-02-04 |
| 61689 | SUPPL | 2020-01-27 |
| 61684 | SUPPL | 2020-01-27 |
| 61683 | SUPPL | 2020-01-27 |
| 61661 | SUPPL | 2020-01-27 |
| 60617 | SUPPL | 2019-10-22 |
| 60601 | SUPPL | 2019-10-21 |
| 60600 | SUPPL | 2019-10-21 |
| 57821 | SUPPL | 2019-02-27 |
| 57802 | SUPPL | 2019-02-25 |
| 56195 | SUPPL | 2018-10-30 |
| 56147 | SUPPL | 2018-10-29 |
| 52234 | SUPPL | 2018-02-01 |
| 47461 | SUPPL | 2017-03-03 |
| 47393 | SUPPL | 2017-03-02 |
| 45093 | SUPPL | 2016-08-22 |
| 45051 | SUPPL | 2016-08-17 |
| 40493 | SUPPL | 2016-06-17 |
| 32701 | SUPPL | 2016-06-16 |
| 40492 | SUPPL | 2015-12-08 |
| 32700 | SUPPL | 2015-12-07 |
| 43498 | ORIG | 2015-04-06 |
| 24500 | ORIG | 2015-04-06 |
| 40491 | ORIG | 2014-11-04 |
| 10486 | ORIG | 2014-10-31 |