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Sign in to subscribeChloroprocaine Hydrochloride Injection
Matched- Active ingredients (original)
- CHLOROPROCAINE HYDROCHLORIDE
- 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 applications3
RLD applicantFRESENIUS KABI USA LLC
Currently marketed products: 5 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A040273-001 | CHLOROPROCAINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 2% | 1998/09/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040273-002 | CHLOROPROCAINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 3% | 1998/09/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A087446-001 | CHLOROPROCAINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 3% | 1982/04/16 | N / N | DISCONTINUED | openFDA ↗ |
| A087447-001 | CHLOROPROCAINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 2% | 1982/04/16 | N / N | DISCONTINUED | openFDA ↗ |
| N009435-001 | NESACAINE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 1% | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N009435-002 | NESACAINE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 2% | Approved before 1982 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009435-003 | NESACAINE-MPF | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 2% | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N009435-004 | NESACAINE-MPF | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 3% | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N009435-006 | NESACAINE-MPF | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 2% | 1996/05/02 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009435-007 | NESACAINE-MPF | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | CHLOROPROCAINE HYDROCHLORIDE: 3% | 1996/05/02 | Y / Y | HUMAN PRESCRIPTION DRUG | 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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H2026375510ml:0.3g | 2026/03/31 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H2026375420ml:0.6g | 2026/03/31 | Official source ↗ |
NHSA approval numbers 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | 国药准字H2002007910ml:300mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H2026375420ml:0.6g | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2002061310ml:0.2g | — | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | 国药准字H2002007910ml:300mg | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2002061310ml:0.2g | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2002061310ml:0.2g | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2002061410ml:0.1g | — | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | 国药准字H2002008120ml:600mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H2026375510ml:0.3g | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2002061410ml:0.1g | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H200206122ml:40mg | — | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | 国药准字H2002008120ml:600mg | — | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | 国药准字H200206122ml:40mg | — | Official source ↗ |
Under review 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601393 | 2026/06/11 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601392 | 2026/06/11 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2504295 | 2025/12/16 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2504294 | 2025/12/16 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHS2600559 | 2026/02/27 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHS2600558 | 2026/02/27 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2601281 | 2026/06/03 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | CYHS2601237 | 2026/06/01 | Official source ↗ |
| Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | CYHS2601220 | 2026/06/01 | Official source ↗ |
| Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | CYHS2601219 | 2026/06/01 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601393 | 2026/06/11 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601392 | 2026/06/11 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHS2600559 | 2026/02/27 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHS2600558 | 2026/02/27 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2601281 | 2026/06/03 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | CYHS2601237 | 2026/06/01 | Official source ↗ |
| Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | CYHS2601220 | 2026/06/01 | Official source ↗ |
| Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | CYHS2601219 | 2026/06/01 | Official source ↗ |
API companies with A status 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20250000470 | 2026/10/12 | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20240000390 | 2025/11/28 | Official source ↗ |
| Shanghai Wan Xiang Pharmaceutical Co., Ltd. romanized | Y20230000222 | 2025/10/11 | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized | Y20190004373 | 2025/07/09 | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | Y20190003995 | 2025/05/29 | 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 ↗ · 44-30 · 2021/08/23
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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