Application 211909

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOSPORINE	CYCLOSPORINE	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
A211909-001	CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB		2025-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211909-001	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	A211909-001	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	2025-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211909-001	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	2025-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211909-001	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	2025-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211909-001	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	2025-11-28	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211909-001	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	2025-11-28	`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	A211909-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211909-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211909-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211909-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211909-001	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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RESTASIS	CYCLOSPORINE	A-S Medication Solutions	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	2024-05-24	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	American Health Packaging	a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
Cyclosporine Modified	CYCLOSPORINE	Teva Pharmaceuticals USA, Inc.	2de1e8b1-625f-43ce-a1d5-d543be208b11	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Teva Pharmaceuticals, Inc.	cc64c1e3-19f5-4bf6-a08d-a9725004c97f	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Mylan Pharmaceuticals Inc.	da3fa070-b512-4568-871a-dc8d5a949d13	2022-01-20	Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE

Reported adverse events (FAERS/openFDA)#

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