Application 206436

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MG;300MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-09

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-0984e616aacf4f…
2026-08-18 06:07:402026-07A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2018-04-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-093f01610625f2…
2019-09-15 20:21 UTC2019-09A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206436-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-04-09f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206436-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206436-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206436-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206436-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206436-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206436-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206436-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206436-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206436-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206436-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206436-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206436-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206436-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206436-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206436-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206436-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206436-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206436-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206436-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206436-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206436-001AB187673890dc5c…
2019-12-14 00:12 UTC2019-12A206436-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206436-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206436-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206436-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206436-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206436-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206436-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206436-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206436-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206436-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206436-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206436-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206436-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206436-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206436-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206436-001AB1cb3db0bc1861…

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 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions41bd03ea-b92e-459c-968b-c9095ae90aef2026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEMajor Pharmaceuticalsa78b51c9-c944-4b00-af81-9ecbfbb29fd12026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENuCare Pharmaceuticals, Inc.4feb83a5-9142-0c67-e063-6394a90a710f2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepackb8c5f114-61db-4797-b75e-c103d2d1820e2026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEProficient Rx LP1289b02c-50f7-4adc-80d1-24afc1bad01b2026-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEStrides Pharma Science Limitedbc37cba9-83c8-4660-a527-cd77fae9ea872026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATERedpharm Drug44f2503d-7863-61a8-e063-6394a90a83c42025-12-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions4d1fd81c-8bb5-4b04-a284-b35f74a955a02025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATELaurus Labs Limited4a7ccbbf-da20-4012-9717-31c411efb3fb2025-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEAvKARE38e06005-b998-9abb-e063-6294a90a71cb2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENuCare Pharmaceuticals, Inc.33149d27-687e-a092-e063-6294a90ab39b2025-04-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATECamber Pharmaceuticals, Inc.7fa6961e-3602-4e31-a60a-e5735899f63b2025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEDirectRxd67e2df4-4094-4f5a-e053-2a95a90ae4aa2025-01-21Warnings, Adverse reactionsName fallback
brand name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENuCare Pharmaceuticals, Inc.23ae0a72-adcf-fdd0-e063-6394a90abe632024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATECipla USA Inc.d08c9455-e788-435c-9076-2bdb1a4f5b372024-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEZydus Lifesciences Limiteda0ee89b6-72c3-4b99-8d1c-d7473f1d5ef32024-11-28Name fallback
brand name: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEProficient Rx LPd3b849a7-219d-4acc-9e29-8f246cb4a7a92024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATETeva Pharmaceuticals USA, Inc.e1e4d828-7870-4ea9-a66a-e658487bd8592024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEQUALLENT PHARMACEUTICALS HEALTH LLC4af2529d-a14f-4337-87ed-04f8f27da7462024-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limitedd8c32565-9ff2-4bfb-a5cf-ae6e0e498ccc2024-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Emtricitabine and Tenofovir Disoproxil Fumarate

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1930Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateMylan Pharmaceuticals Inc.ANDACurrent