Application 207284

Type: ANDA
Sponsor: EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFLUPREDNATE	DIFLUPREDNATE	EMULSION;OPHTHALMIC	0.05%	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207284-001	DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB		2024-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207284-001	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.

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	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207284-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2024-05-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207284-001	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207284-001	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Difluprednate	DIFLUPREDNATE	Mylan Pharmaceuticals Inc.	4a3b2649-ee3d-4648-91c8-912a8ba2e73c	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Difluprednate generic name: DIFLUPREDNATE
Difluprednate	DIFLUPREDNATE OPHTHALMIC	Amneal Pharmaceuticals NY LLC	3612ff2a-c4bf-4322-b5bc-e7b867575321	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Difluprednate
Difluprednate	DIFLUPREDNATE	Upsher-Smith Laboratories, LLC	ce8c1d56-771e-45da-8a19-5f881f993738	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Difluprednate generic name: DIFLUPREDNATE
Difluprednate	DIFLUPREDNATE OPHTHALMIC	Alembic Pharmaceuticals Inc.	bfc27bfe-b05e-4531-b724-7727a46f6f8a	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Difluprednate
Difluprednate	DIFLUPREDNATE OPHTHALMIC	Alembic Pharmaceuticals Limited	71121026-1496-4154-b61b-9afe9b62bf2a	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Difluprednate
DUREZOL	DIFLUPREDNATE	Sandoz Inc	ea520a27-f569-4b31-8bad-a25ad54b2caa	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: DIFLUPREDNATE
DIFLUPREDNATE	DIFLUPREDNATE	Leading Pharma, LLC	054ca798-454a-41cc-9d08-97bb8bef5620	2025-02-08	Warnings, Adverse reactions	Name fallback brand name: DIFLUPREDNATE generic name: DIFLUPREDNATE
Difluprednate	DIFLUPREDNATE	Caplin Steriles Limited	0f9a1987-6a04-4764-94e5-7053997c058b	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Difluprednate generic name: DIFLUPREDNATE
DIFLUPREDNATE	DIFLUPREDNATE	Cipla USA Inc.	8a7254de-a7a2-476d-9295-c41926267ec9	2020-04-10	Warnings, Adverse reactions	Name fallback brand name: DIFLUPREDNATE generic name: DIFLUPREDNATE