FDA.reportPublic FDA data

Application 201802

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL600MG;200MG;300MGNoNo
002EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo
003EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL600MGNoNo

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

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
A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03

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
2026-08-18 06:07:402026-07A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-038072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2023-10-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2023-10-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2023-10-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2023-10-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORALAB2023-10-039b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201802-001EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MGTABLET / ORAL2023-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201802-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201802-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201802-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201802-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201802-001AB19b2671bbb829…