Application 214053

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	120MG;EQ 15MG BASE	No	No
002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	200MG;EQ 25MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL			2024-05-17
A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL			2024-05-17

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL	AB	2024-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL	AB	2024-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL	AB	2024-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL	AB	2024-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL	AB	2024-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL	AB	2024-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL	AB	2024-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL	AB	2024-05-17	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214053-001	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		2024-05-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214053-002	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL		2024-05-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214053-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214053-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214053-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214053-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214053-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214053-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214053-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214053-002	AB	1	`1e350fbaab3a…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78836	ORIG	2024-06-20