Application 216046

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	25MG	No	No
002	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	50MG	No	No
003	CYCLOSPORINE	CYCLOSPORINE	CAPSULE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216046-001	CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02
A216046-002	CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02
A216046-003	CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216046-001	AB1
A216046-002	AB1
A216046-003	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216046-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216046-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216046-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216046-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216046-001	AB1	1	`1e350fbaab3a…`

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	CYCLOSPORINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1952d4c7-a40e-4924-b669-c41400774cb9	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216046 application number: ANDA216046 ndc (product): 23155-839 ndc (product): 23155-837 ndc (product): 23155-838

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-837	CYCLOSPORINE	CYCLOSPORINE	Avet Pharmaceuticals Inc	ANDA	Current
23155-838	CYCLOSPORINE	CYCLOSPORINE	Avet Pharmaceuticals Inc	ANDA	Current
23155-839	CYCLOSPORINE	CYCLOSPORINE	Avet Pharmaceuticals Inc	ANDA	Current
64380-127	Cyclosporine	Cyclosporine	Strides Pharma Science Limited	ANDA	Current
64380-128	Cyclosporine	Cyclosporine	Strides Pharma Science Limited	ANDA	Current
64380-129	Cyclosporine	Cyclosporine	Strides Pharma Science Limited	ANDA	Current