Home Applications 212632 Application 212632
Type ANDA
Sponsor STRIDES PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG No No 002 FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212632-001 FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 A212632-002 FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 76 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL 2020-04-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL 2020-04-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL 2020-04-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
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 Flucytosine FLUCYTOSINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. f4c63d98-f03f-43f5-8c1f-e9ac6087312b 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212632 application number: ANDA212632
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 64380-897 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current 64380-897 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current 64380-897 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current 64380-898 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current 64380-898 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current 64380-898 Flucytosine Flucytosine Strides Pharma Science Limited ANDA Current