Application 207971

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FINGOLIMOD	FINGOLIMOD	CAPSULE;ORAL	0.5MG	No	No

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

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
A207971-001	FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL			2020-06-29

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
2026-08-18 06:07:40	2026-07	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-06-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207971-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-06-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207971-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207971-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207971-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207971-001	AB	1	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A207971-001	PC	2023-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207971-001	PC	2023-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207971-001	PC	2023-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207971-001	PC	2023-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207971-001	PC	2023-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207971-001	PC	2023-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207971-001	PC	2023-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207971-001	PC	2023-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207971-001	PC	2023-03-20	`f41ea6bd6efb…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FINGOLIMOD	FINGOLIMOD	Quallent Pharmaceuticals Health LLC	5434bd4a-2610-0e17-4f14-513ff1cbb822	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: FINGOLIMOD generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	CivicaScript LLC	e1960f9b-f739-452c-b167-245551bf3690	2026-05-25	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Alembic Pharmaceuticals Limited	d0538769-3cec-4cf2-97e5-41e79599c181	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Alembic Pharmaceuticals Inc.	54bf842e-9772-424d-87b2-61863b6f4b19	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD HYDROCHLORIDE	Ascend Laboratories, LLC	0f638feb-6986-41e4-8f9c-2e6b84a5bb44	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Fingolimod
fingolimod	FINGOLIMOD	Glenmark Pharmaceuticals Inc., USA	8fe14efd-8f61-40db-9069-bb17daf3261a	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	AvKARE	1171df44-48b4-6ef2-e063-6294a90aa121	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
FINGOLIMOD	FINGOLIMOD	Aurobindo Pharma Limited	d6301307-55c6-4b91-a505-ff93c865f859	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: FINGOLIMOD generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Camber Pharmaceuticals, Inc.	c3199508-3d6a-4e44-96f0-bbde9969edcb	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
FINGOLIMOD	FINGOLIMOD	Biocon Pharma Inc.	550a5fa3-94a4-0b55-9cb5-c0178acfe319	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: FINGOLIMOD generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Teva Pharmaceuticals, Inc.	d9aa1078-fd72-47ef-84b2-2e1ad17b12a2	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Dr. Reddy's Laboratories Inc	56badc2a-6747-9284-300e-bf072eb072ed	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Apotex Corp.	a545c6fc-7006-52c2-f476-34e9801ac04f	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Sun Pharmaceutical Industries, Inc.	b228dac8-b07d-424d-b23b-a03573517c54	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Zydus Pharmaceuticals USA Inc.	e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	Zydus Lifesciences Limited	5a0319b4-4bc6-4564-9687-9cfd5c1b23a8	2024-11-30		Name fallback brand name: Fingolimod generic name: FINGOLIMOD
fingolimod	FINGOLIMOD HCL	Rising Pharma Holdings, Inc.	99e7daf4-ea90-5e47-e053-2a95a90ac1b7	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: fingolimod
FINGOLIMOD	FINGOLIMOD	Solco Healthcare US, LLC	6c0faf2b-21fb-4830-bb78-5f2dbceb2c82	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: FINGOLIMOD generic name: FINGOLIMOD
Fingolimod	FINGOLIMOD	XLCare Pharmaceuticals Inc.	c5402dd1-c496-405d-9cae-07ccf184339c	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Fingolimod generic name: FINGOLIMOD

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-776	FINGOLIMOD	fingolimod	Strides Pharma Science Limited	ANDA	Current