Application 213774

Type: ANDA
Sponsor: ALEMBIC

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 43.

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
A213774-001	DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB		2026-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213774-001	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
2026-09-14 22:38:34	2026-08	A213774-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2026-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213774-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2026-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213774-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2026-01-26	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213774-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2026-01-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213774-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213774-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213774-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213774-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Difluprednate	DIFLUPREDNATE OPHTHALMIC	Alembic Pharmaceuticals Limited	71121026-1496-4154-b61b-9afe9b62bf2a	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213774 application number: ANDA213774

Reported adverse events (FAERS/openFDA)#

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