Monthly
US$200
Billed every month
Sign in to subscribeCyclophosphamide Injection
Matched- Active ingredients (original)
- CYCLOPHOSPHAMIDE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approvalApproved before 1982
ANDA applications15
RLD applicantBAXTER HEALTHCARE CORP
Currently marketed products: 27 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A040015-001 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-002 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-003 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-004 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040015-005 | NEOSAR | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 1993/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A040745-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040745-002 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040745-003 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2008/05/21 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A087442-001 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-002 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-003 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1982/02/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-004 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1983/07/08 | N / N | DISCONTINUED | openFDA ↗ |
| A087442-005 | NEOSAR | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 1989/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A088371-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088372-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088373-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 1986/07/03 | N / N | DISCONTINUED | openFDA ↗ |
| A088374-001 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 1986/09/24 | N / N | DISCONTINUED | openFDA ↗ |
| A204555-001 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204555-002 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204555-003 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2014/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-001 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-002 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210046-003 | CYCLOPHOSPHAMIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2018/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-001 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-002 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211757-003 | CYCLOPHOSPHAMIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2022/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-001 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-002 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214529-003 | CYCLOPHOSPHAMIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/07/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-001 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-002 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215089-003 | CYCLOPHOSPHAMIDE | SUNNY PHARMTECH INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-001 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-002 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216958-003 | CYCLOPHOSPHAMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2023/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-001 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-002 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218632-003 | CYCLOPHOSPHAMIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2024/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-001 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-002 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218644-003 | CYCLOPHOSPHAMIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL | 2024/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N012142-001 | CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-002 | CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-003 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-004 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982/08/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-005 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982/08/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-006 | LYOPHILIZED CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/05 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-007 | LYOPHILIZED CYTOXAN | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-008 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1984/01/04 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-009 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/12/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N012142-010 | CYTOXAN (LYOPHILIZED) | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | CYCLOPHOSPHAMIDE: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/09/24 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601403 | 2026/06/12 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600376 | 2026/02/05 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600375 | 2026/02/05 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600374 | 2026/02/05 | Official source ↗ |
| Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2503216 | 2025/09/02 | Official source ↗ |
| Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2503215 | 2025/09/02 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601403 | 2026/06/12 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600376 | 2026/02/05 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600375 | 2026/02/05 | Official source ↗ |
| Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized | CYHS2600374 | 2026/02/05 | Official source ↗ |
API companies with A status 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Lian Yun Gang Gui Ke Pharma Co., Ltd. romanized | Y20230001208 | 2026/07/18 | Official source ↗ |
| MSN Laboratories Private Limited | Y20210000587 | 2025/03/14 | Official source ↗ |
| Anhui Pu Li Pharma Co., Ltd. romanized | Y20220000793 | 2024/05/22 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190009631 | 2025/08/01 | Official source ↗ |
| Shanxi Pu De Pharma Co., Ltd. romanized | Y20190007404 | 2026/10/10 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190007332 | 2023/05/25 | Official source ↗ |
| Tong Hua Mao Xiang Pharmaceutical Co., Ltd. romanized | Y20190005033 | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190001726 | 2025/01/25 | Official source ↗ |
| Beijing Si Li An Pharma Co., Ltd. romanized | Y20190001681 | 2024/08/21 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20180000542 | 2026/05/08 | Official source ↗ |
| Guangdong Ling Nan Pharmaceutical Co., Ltd. romanized | Y20170000200 | 2024/09/12 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 60-19 · 2022/10/11
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy