Application 065025

Type: ANDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOSPORINE	CYCLOSPORINE	SOLUTION;ORAL	100MG/ML	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
A065025-001	CYCLOSPORINE	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL			2000-03-03

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 2 · 41 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	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL		2000-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL		2000-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL		2000-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL		2000-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065025-001	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL	AB1	2000-03-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065025-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065025-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065025-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065025-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065025-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065025-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065025-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065025-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065025-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065025-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065025-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065025-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065025-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065025-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065025-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065025-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065025-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065025-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065025-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065025-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065025-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065025-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065025-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065025-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065025-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065025-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065025-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065025-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065025-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065025-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065025-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065025-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065025-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065025-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065025-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065025-001	AB1	1	`cb3db0bc1861…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neoral	CYCLOSPORINE	Novartis Pharmaceuticals Corporation	94461af3-11f1-4670-95d4-2965b9538ae3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Sandimmune	CYCLOSPORINE	Novartis Pharmaceuticals Corporation	5e5926a7-1de0-4b54-a5c0-286b6200ff82	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
CEQUA	CYCLOSPORINE	Sun Pharmaceutical Industries, Inc.	48c3d8a3-4289-4b52-9189-58b48596095c	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Verkazia	CYCLOSPORINE	Harrow Eye, LLC	48651d30-9e6e-74b0-e063-6294a90a8337	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
CYCLOSPORINE	CYCLOSPORINE	Upsher-Smith Laboratories, LLC	f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: CYCLOSPORINE generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Apotex Corp.	bfca7088-fe93-abb9-3ec3-e6f5710a69c6	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
CYCLOSPORINE	CYCLOSPORINE	Saptalis Pharmaceuticals, LLC	ff4dc2fc-667a-489a-b798-8d11cddfe716	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: CYCLOSPORINE generic name: CYCLOSPORINE
CYCLOSPORINE	CYCLOSPORINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1952d4c7-a40e-4924-b669-c41400774cb9	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CYCLOSPORINE generic name: CYCLOSPORINE
CycloSPORINE, Modfied	CYCLOSPORINE	Apotex Corp.	5baaf78c-90f6-abcf-52c8-814490f3cf9f	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Restasis MultiDose	CYCLOSPORINE	Allergan, Inc.	7224d810-bb96-4682-a942-3355e6e8061a	2025-08-21	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Devatis Inc.	7bb2078d-17c2-4e6a-9f61-26c7ecbce945	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
Verkazia	CYCLOSPORINE	Santen Incorporated	c795cd2f-89da-78e3-e053-2a95a90a9422	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Apotex Corp	70c8a4a6-ebe2-457f-a626-400c338cec2d	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	KVK-TECH, INC.	a7040dc6-063b-40ee-8f2a-153e87b08430	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
RESTASIS	CYCLOSPORINE	Allergan, Inc.	8e24af2b-bc1c-4849-94f2-6df950cdca89	2024-09-09	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
CYCLOSPORINE	CYCLOSPORINE	Lupin Pharmaceuticals, Inc.	9aca2026-af86-4e97-925e-c202b87c46ac	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: CYCLOSPORINE generic name: CYCLOSPORINE
Gengraf	CYCLOSPORINE	AbbVie Inc.	e896cbfe-4745-4088-82a3-8dc10b75c41f	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Teva Pharmaceuticals USA, Inc.	f3dc2a50-1084-4190-a6f3-37034a04db86	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
Cyclosporine	CYCLOSPORINE	Dr. Reddy's Laboratories Inc	64ec430a-e930-145c-e766-13fb49b64644	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cyclosporine generic name: CYCLOSPORINE
RESTASIS	CYCLOSPORINE	A-S Medication Solutions	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	2024-05-24	Warnings, Adverse reactions	Name fallback generic name: CYCLOSPORINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-7269	Gengraf	Cyclosporine	AbbVie Inc.	ANDA	Current
0074-7269	Gengraf	Cyclosporine	AbbVie Inc.	ANDA	Current
0074-7269	Gengraf	Cyclosporine	AbbVie Inc.	ANDA	Current
0074-7269	Gengraf	Cyclosporine	AbbVie Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22303	ORIG	2001-06-07
30628	ORIG	2000-03-03