FDA.reportPublic FDA data

Application 211467

Type
ANDA
Sponsor
MICRO LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZINDAPAGLIFLOZINTABLET;ORAL5MGNoNo
002DAPAGLIFLOZINDAPAGLIFLOZINTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211467-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211467-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211467-001AB
A211467-002AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211467-001PC2026-10-03
A211467-002PC2026-10-03

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
2026-09-14 22:38:342026-08A211467-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211467-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A211467-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211467-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211467-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211467-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A211467-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211467-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08A211467-001PC2026-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A211467-002PC2026-10-0384e616aacf4f…
2026-08-18 06:07:402026-07A211467-001PC2026-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211467-002PC2026-10-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-001PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211467-002PC2026-10-03a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZINDAPAGLIFLOZINAlembic Pharmaceuticals Limitedd44f7eed-dd51-40d1-8408-8fb331e1f1f62026-04-21Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINApotex Corp.bd9766c5-104f-4636-897d-b6c92eb94f182026-04-10Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINZydus Lifesciences Limiteddb668c5c-2d49-41c8-8ffd-c2b2652b621a2026-04-06Name fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINBryant Ranch Prepack979205ee-b0b8-4483-ae61-f283f750bb7f2024-08-08Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions82cdd5ad-df2b-4bdd-a3a6-a059040100b42024-06-28Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions87521963-0d2a-4a2a-89c6-d50e8582419e2024-06-28Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59244ORIG2019-07-05