FDA.reportPublic FDA data

Application 209550

Type
ANDA
Sponsor
CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209550-001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-263f01610625f2…
2019-09-15 20:21 UTC2019-09A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORAL2018-02-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209550-001TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-02-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209550-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209550-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209550-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209550-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209550-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209550-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209550-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209550-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209550-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209550-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209550-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209550-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209550-001AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209550-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209550-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209550-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209550-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209550-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209550-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209550-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209550-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209550-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209550-001AB1cb3db0bc1861…

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 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42385-901Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateLaurus Labs LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53557ORIG2018-03-30