Home Applications 203856 Application 203856
Type NDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CAPSULE;ORAL 25MG Yes No 002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CAPSULE;ORAL 50MG Yes Yes
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 N203856-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 N203856-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16
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 3 · 84 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 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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.
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 0054-0382 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current 0054-0382 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current 0054-0382 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current 0054-0383 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current 0054-0383 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current 0054-0383 Cyclophosphamide Cyclophosphamide West-Ward Pharmaceuticals Corp. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60214 SUPPL 2019-10-03 60143 SUPPL 2019-09-27 43446 ORIG 2014-03-06 24451 ORIG 2014-03-06 10254 ORIG 2013-09-19 40329 ORIG 2013-09-18