Application 091612

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo
002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL150MGNoNo
003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MGNoNo
004TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL250MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091612-001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18
A091612-002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26
A091612-003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26
A091612-004TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091612-001AB
A091612-002AB
A091612-003AB
A091612-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2015-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-002TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-003TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-004TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091612-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091612-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091612-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091612-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091612-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091612-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091612-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091612-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091612-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091612-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091612-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091612-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091612-004AB1d8e5a09893c0…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepacke0ae0aa2-3baa-4b75-9e85-68b5338c3c142026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEAvKARE7f0bc342-0a0a-1d28-e053-2991aa0a28b92026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATEAvPAKa215f64c-84de-0649-e053-2a95a90a9d592026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TENOFOVIR DISOPROXIL FUMARATE
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEPD-Rx Pharmaceuticals, Inc.08a30772-02fc-4f63-e063-6394a90afd432025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepack3285f345-e58d-4831-a6a8-31094c8c546d2025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATEStrides Pharma Science Limitedbcd3120b-60f6-41d8-a512-ed4a62c836b42025-08-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TENOFOVIR DISOPROXIL FUMARATE
generic name: TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarateTENOFOVIR DISOPROXIL FUMARATEMajor Pharmaceuticalsda78a5d3-f5c6-47fe-b593-3252704c225d2025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tenofovir disoproxil fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarateTENOFOVIR DISOPROXIL FUMARATEMacleods Pharmaceuticals Limited532755cb-1cd3-4774-97af-05a53779b65f2025-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tenofovir disoproxil fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.33fd6418-fbdc-42ca-a50d-ce2a476a54182025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEFlorida Pharmaceutical Products, LLC.0c7d72d6-bf80-49e0-921c-20169e87e62f2025-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEQuinn Pharmaceuticals92569e53-507e-7a5b-e053-2995a90aca352025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions67e0e1b7-6a45-4d63-b569-00826832c25a2024-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limiteda75c6be8-3719-4bb3-8a9e-06e5254d2a822024-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir disoproxil fumarateTENOFOVIR DISOPROXIL FUMARATECipla USA Inc.de27413a-6579-4586-80dc-39c7126529522024-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir disoproxil fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepack18285dda-d63f-4f0e-821f-a4f2df335c352023-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATECamber Pharmaceuticals, Inc.1ac4c628-f01f-42d4-b8e6-d12273aefc6d2023-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE TABLETSChartwell RX, LLC.9cf11bd3-01b9-4ac8-96cc-55d57998b51d2022-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATENorthStar RxLLCeaeb1670-4e39-4541-8ff7-47057f3f5c362018-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tenofovir Disoproxil Fumarate
generic name: TENOFOVIR DISOPROXIL FUMARATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7104Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
70518-0918Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateREMEDYREPACK INC.ANDACurrent
70518-0918Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9347ORIG2015-03-20