Application 065110

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	50MG	No	No
002	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	100MG	No	No
003	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	25MG	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
A065110-001	CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29
A065110-002	CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29
A065110-003	CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065110-001	AB1
A065110-002	AB1
A065110-003	AB1

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	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-002	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2005-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-003	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2005-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065110-001	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2005-03-29	`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	A065110-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065110-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065110-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065110-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065110-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065110-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065110-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065110-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065110-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065110-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065110-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065110-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065110-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065110-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065110-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065110-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065110-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065110-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065110-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065110-001	AB1	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclosporine Modified	CYCLOSPORINE	Teva Pharmaceuticals USA, Inc.	2de1e8b1-625f-43ce-a1d5-d543be208b11	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065110 application number: ANDA065110 ndc (product): 0093-9020 ndc (product): 0093-9019 ndc (product): 0093-9018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5740	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5740	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5740	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5740	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5741	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5741	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5741	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5741	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5742	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5742	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5742	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5742	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9018	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9018	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9019	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9019	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9020	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9020	Cyclosporine	Cyclosporine	Teva Pharmaceuticals USA, Inc.	ANDA	Current