Home Applications 210735 Application 210735
Type NDA
Sponsor AUROMEDICS PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE SOLUTION;INTRAVENOUS 500MG/2.5ml (200MG/ML) Yes No 002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE SOLUTION;INTRAVENOUS 1GM/5ML (200MG/ML) Yes No 003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE SOLUTION;INTRAVENOUS 2GM/10ML (200MG/ML) Yes Yes
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 RLD / RS Approval date N210735-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 N210735-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 N210735-003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210735-001 9662342 2035-06-26 Drug product 2021-09-03 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 N210735-003 9662342 2035-06-26 Drug product 2023-11-29
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.
Product history page 1 of 3 · 87 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 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 3 · 87 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55150-270 Cyclophosphamide Cyclophosphamide AuroMedics Pharma LLC NDA Current 55150-270 Cyclophosphamide Cyclophosphamide AuroMedics Pharma LLC NDA Current 55150-271 Cyclophosphamide Cyclophosphamide AuroMedics Pharma LLC NDA Current 55150-271 Cyclophosphamide Cyclophosphamide AuroMedics Pharma LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76670 ORIG 2023-11-28 76644 SUPPL 2023-11-21 76637 SUPPL 2023-11-21 70814 ORIG 2022-04-26 68480 ORIG 2021-08-27