FDA.reportPublic FDA data

Application 211640

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL100MG;150MGNoNo
002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL133MG;200MGNoNo
003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL167MG;250MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09
A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09
A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211640-001AB
A211640-002AB
A211640-003AB

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.

Product history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-0984e616aacf4f…
2026-08-18 06:07:402026-07A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2023-03-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2023-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211640-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2023-03-09301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211640-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211640-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211640-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A211640-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211640-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211640-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211640-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211640-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211640-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211640-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211640-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211640-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211640-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211640-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211640-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211640-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211640-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211640-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211640-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211640-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211640-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211640-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211640-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211640-001AB1301d65b070ca…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limited974d2ec8-1b51-4e69-991d-0d5dea8360f42024-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211640
application number: ANDA211640

Reported adverse events (FAERS/openFDA)#

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