Application 209498

Type: ANDA
Sponsor: QILU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	200MG	No	No
002	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	250MG	No	No
003	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209498-001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02
A209498-002	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02
A209498-003	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209498-001	AB
A209498-002	AB
A209498-003	AB

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 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209498-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209498-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209498-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209498-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209498-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Bryant Ranch Prepack	e0ae0aa2-3baa-4b75-9e85-68b5338c3c14	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Bryant Ranch Prepack	3285f345-e58d-4831-a6a8-31094c8c546d	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Florida Pharmaceutical Products, LLC.	0c7d72d6-bf80-49e0-921c-20169e87e62f	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Quinn Pharmaceuticals	92569e53-507e-7a5b-e053-2995a90aca35	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498 ndc (product): 69076-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-4666	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Apotex Corp.	ANDA	Current
67184-0519	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0519	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0519	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0520	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0520	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0520	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0521	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0521	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0521	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
69076-105	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-105	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-105	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Quinn Pharmaceuticals	ANDA	Current
69076-105	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Quinn Pharmaceuticals	ANDA	Current