Application 205649

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;500MGYesNo
002XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMYesNo
003XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;500MGYesNo
004XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMYesYes
005XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GMYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205649-001XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29
N205649-002XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29
N205649-003XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29
N205649-004XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2014-10-29
N205649-005XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD2017-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N205649-001AB
N205649-002AB
N205649-003AB
N205649-004AB
N205649-005AB

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205649-00165151172025-10-04U-493Drug substance, Drug product2014-11-24
N205649-0016515117*PED2026-04-04Pediatric extension
N205649-00185016982027-06-20U-493Drug product2014-11-24
N205649-0018501698*PED2027-12-20Pediatric extension
N205649-00179195982029-12-16Drug substance2014-11-24
N205649-00186859342030-05-26U-15222014-11-24
N205649-0017919598*PED2030-06-16Pediatric extension
N205649-00196160282030-11-12Drug product2017-08-30
N205649-0018685934*PED2030-11-26Pediatric extension
N205649-0019616028*PED2031-05-12Pediatric extension
N205649-00265151172025-10-04U-493Drug substance, Drug product2014-11-24
N205649-0026515117*PED2026-04-04Pediatric extension
N205649-00285016982027-06-20U-493Drug product2014-11-24
N205649-0028501698*PED2027-12-20Pediatric extension
N205649-00279195982029-12-16Drug substance2014-11-24
N205649-00286859342030-05-26U-15222014-11-24
N205649-0027919598*PED2030-06-16Pediatric extension
N205649-00296160282030-11-12Drug product2017-08-30
N205649-0028685934*PED2030-11-26Pediatric extension
N205649-0029616028*PED2031-05-12Pediatric extension
N205649-00365151172025-10-04U-493Drug substance, Drug product2014-11-24
N205649-0036515117*PED2026-04-04Pediatric extension
N205649-00385016982027-06-20U-493Drug product2014-11-24
N205649-0038501698*PED2027-12-20Pediatric extension
N205649-00379195982029-12-16Drug substance2014-11-24
N205649-00386859342030-05-26U-15222014-11-24
N205649-0037919598*PED2030-06-16Pediatric extension
N205649-00396160282030-11-12Drug product2017-08-30
N205649-0038685934*PED2030-11-26Pediatric extension
N205649-0039616028*PED2031-05-12Pediatric extension
N205649-00465151172025-10-04U-493Drug substance, Drug product2014-11-24
N205649-0046515117*PED2026-04-04Pediatric extension
N205649-00485016982027-06-20U-493Drug product2014-11-24
N205649-0048501698*PED2027-12-20Pediatric extension
N205649-00479195982029-12-16Drug substance2014-11-24
N205649-00486859342030-05-26U-15222014-11-24
N205649-0047919598*PED2030-06-16Pediatric extension
N205649-00496160282030-11-12Drug product2017-08-30
N205649-0048685934*PED2030-11-26Pediatric extension
N205649-0049616028*PED2031-05-12Pediatric extension
N205649-00565151172025-10-04U-493Drug substance, Drug product2014-11-24
N205649-0056515117*PED2026-04-04Pediatric extension
N205649-00585016982027-06-20U-493Drug product2017-08-30
N205649-0058501698*PED2027-12-20Pediatric extension
N205649-00579195982029-12-16Drug substance2017-08-30
N205649-00586859342030-05-26U-15222017-08-30
N205649-0057919598*PED2030-06-16Pediatric extension
N205649-00596160282030-11-12Drug product2017-08-30
N205649-0058685934*PED2030-11-26Pediatric extension
N205649-0059616028*PED2031-05-12Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N205649-001NPP2027-06-12
N205649-001PED2027-12-12
N205649-002NPP2027-06-12
N205649-002PED2027-12-12
N205649-003NPP2027-06-12
N205649-003PED2027-12-12
N205649-004NPP2027-06-12
N205649-004PED2027-12-12
N205649-005NPP2027-06-12
N205649-005PED2027-12-12

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N205649-001XIGDUO XR5MG;500MGTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29a50c72e98297…
2026-08-01 22:54:322026-06N205649-002XIGDUO XR5MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29a50c72e98297…
2026-08-01 22:54:322026-06N205649-003XIGDUO XR10MG;500MGTABLET, EXTENDED RELEASE / ORALABRLD2014-10-29a50c72e98297…
2026-08-01 22:54:322026-06N205649-004XIGDUO XR10MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2014-10-29a50c72e98297…
2026-08-01 22:54:322026-06N205649-005XIGDUO XR2.5MG;1GMTABLET, EXTENDED RELEASE / ORALABRLD2017-07-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N205649-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N205649-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N205649-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N205649-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N205649-005AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205649-00165151172025-10-04U-493Drug substance, Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0016515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00185016982027-06-20U-493Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0018501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00179195982029-12-16Drug substance2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-00186859342030-05-26U-15222014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0017919598*PED2030-06-16Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00196160282030-11-12Drug product2017-08-30a50c72e98297…
2026-08-01 22:54:322026-06N205649-0018685934*PED2030-11-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-0019616028*PED2031-05-12Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00265151172025-10-04U-493Drug substance, Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0026515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00285016982027-06-20U-493Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0028501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00279195982029-12-16Drug substance2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-00286859342030-05-26U-15222014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0027919598*PED2030-06-16Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00296160282030-11-12Drug product2017-08-30a50c72e98297…
2026-08-01 22:54:322026-06N205649-0028685934*PED2030-11-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-0029616028*PED2031-05-12Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00365151172025-10-04U-493Drug substance, Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0036515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00385016982027-06-20U-493Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0038501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00379195982029-12-16Drug substance2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-00386859342030-05-26U-15222014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0037919598*PED2030-06-16Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00396160282030-11-12Drug product2017-08-30a50c72e98297…
2026-08-01 22:54:322026-06N205649-0038685934*PED2030-11-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-0039616028*PED2031-05-12Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00465151172025-10-04U-493Drug substance, Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0046515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00485016982027-06-20U-493Drug product2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0048501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00479195982029-12-16Drug substance2014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-00486859342030-05-26U-15222014-11-24a50c72e98297…
2026-08-01 22:54:322026-06N205649-0047919598*PED2030-06-16Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-00496160282030-11-12Drug product2017-08-30a50c72e98297…
2026-08-01 22:54:322026-06N205649-0048685934*PED2030-11-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N205649-0049616028*PED2031-05-12Pediatric extensiona50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N205649-001NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-001PED2027-12-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-002NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-002PED2027-12-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-003NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-003PED2027-12-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-004NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-004PED2027-12-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-005NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N205649-005PED2027-12-12a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrasco Laboratorieseaf135b6-e378-4f62-a1e7-db45e23668c72024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 205649
application number: NDA205649
XIGDUO XRDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAstraZeneca Pharmaceuticals LPac8a0f7b-9f69-4495-abbc-3a47cd75a8592024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 205649
application number: NDA205649
ndc (product): 0310-6260
ndc (product): 0310-6225
ndc (product): 0310-6270
ndc (product): 0310-6250
ndc (product): 0310-6280

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80707SUPPL 2024-12-26
80700SUPPL 2024-12-23
80699SUPPL 2024-12-23
78791SUPPL 2024-06-13
78790SUPPL 2024-06-13
75426SUPPL 2023-09-13
75413SUPPL 2023-09-13
72372SUPPL2022-10-17
72371SUPPL2022-10-17
72328SUPPL2022-10-14
70761SUPPL2022-04-14
70760SUPPL2022-04-14
70752SUPPL2022-04-12
70102SUPPL2022-02-07
70101SUPPL2022-02-07
70092SUPPL2022-02-04
61775SUPPL2020-02-04
61772SUPPL2020-02-04
61771SUPPL2020-02-04
61689SUPPL2020-01-27
61684SUPPL2020-01-27
61683SUPPL2020-01-27
61661SUPPL2020-01-27
60617SUPPL2019-10-22
60601SUPPL2019-10-21
60600SUPPL2019-10-21
57821SUPPL2019-02-27
57802SUPPL2019-02-25
56195SUPPL2018-10-30
56147SUPPL2018-10-29
52234SUPPL2018-02-01
47461SUPPL2017-03-03
47393SUPPL2017-03-02
45093SUPPL2016-08-22
45051SUPPL2016-08-17
40493SUPPL2016-06-17
32701SUPPL2016-06-16
40492SUPPL2015-12-08
32700SUPPL2015-12-07
43498ORIG2015-04-06
24500ORIG2015-04-06
40491ORIG2014-11-04
10486ORIG2014-10-31