FDA.reportPublic FDA data

Application 214216

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATEEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL200MG;EQ 25MG BASENoNo

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
A214216-001EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATEEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASETABLET / ORALAB2026-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214216-001AB

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
2026-09-14 22:38:342026-08A214216-001EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASETABLET / ORALAB2026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07A214216-001EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASETABLET / ORALAB2026-04-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214216-001EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASETABLET / ORALAB2026-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214216-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A214216-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214216-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81189ORIG 2025-02-10