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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZINDAPAGLIFLOZINBryant Ranch Prepack05c3cf00-8c2a-4227-958a-fa5db34512b02026-09-08Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINBiocon Pharma Inc.828f1004-3647-9a13-8008-c4b3759ecfd02026-08-21Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINSandoz Inc8296f538-4c23-4d6c-be53-8005b83c24b72026-07-30Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINAurobindo Pharma Limitedf56593f7-588e-489d-9fad-b459e90dab182026-07-17Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINA-S Medication Solutions01f90c94-71cb-4a1f-81ff-8004b850529b2026-07-10Warnings, Adverse reactionsName fallback
generic name: DAPAGLIFLOZIN
dapagliflozinDAPAGLIFLOZINMacleods Pharmaceuticals Limited91373924-66dc-4277-aaf2-8536e81a0e4d2026-07-09Warnings, Adverse reactionsName fallback
brand name: dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINFlorida Pharmaceutical Products, LLC20a83ea2-6ad8-4bbb-b516-73c0a9e373992026-07-02Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINANI Pharmaceuticals, Inc.6425d240-5dd9-4a2c-9348-f8a8597028502026-06-29Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINLupin Pharmaceuticals, Inc.08baca21-e39e-4e61-961f-d89432fe80072026-06-26Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINAscend Laboratories, LLCb6b8a10c-64c3-4856-8961-d72d68784f5d2026-06-25Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINAlembic Pharmaceuticals Inc.840e2146-2383-489b-bcc4-fecfe986685a2026-06-23Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINZydus Pharmaceuticals USA Inc.17586ec6-0104-4b08-ad87-12a837568d6c2026-06-22Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINCipla USA Inc.a2f86c0a-ce78-4d06-b5d8-ed457c8e36142026-06-22Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINTeva Pharmaceuticals, Inc.0406a1c0-56b1-4ea1-95ae-00357ac1ba7e2026-06-21Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINNovadoz Pharmaceuticals LLC107b4d25-4764-42b7-80e3-9aaff20865ed2026-06-17Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINPrasco Laboratories3aba33aa-f8c6-4b10-85c8-dfa14578d07c2026-06-03Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LP72ad22ae-efe6-4cd6-a302-98aaee423d692026-06-03Warnings, Adverse reactionsName fallback
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINAvKARE52a778e7-6044-2049-e063-6294a90aa0b72026-05-27Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f2026-05-18Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsc4264ff6-5199-49e9-91d3-3ad67b42f88d2026-05-18Warnings, 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