Application 207994

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDECAPSULE;ORALEQ 0.5MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207994-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207994-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-148869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-10-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207994-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207994-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207994-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207994-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207994-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207994-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207994-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207994-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207994-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207994-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207994-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207994-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207994-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207994-001AB18072bd15b7f6…
2021-03-12 10:30 UTC2021-03A207994-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207994-001AB18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207994-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207994-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207994-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207994-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207994-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207994-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207994-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207994-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207994-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207994-001AB13a93d1ddd44b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207994-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FingolimodFINGOLIMODZydus Pharmaceuticals USA Inc.e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b32025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207994
application number: ANDA207994
ndc (product): 68382-912
FingolimodFINGOLIMODZydus Lifesciences Limited5a0319b4-4bc6-4564-9687-9cfd5c1b23a82024-11-30Exact identifier
application applno (ANDA): 207994
application number: ANDA207994
ndc (product): 70771-1603

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-912FingolimodFingolimodZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1603FingolimodFingolimodZydus Lifesciences LimitedANDACurrent
70771-1603FingolimodFingolimodZydus Lifesciences LimitedANDACurrent