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Sign in to subscribeEbastine Oral Solution
As of 13 November 2026, for Ebastine Oral Solution, 9 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 1 applicationNo longer listed under review: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders0View records ↓
Under-review filings9View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers12View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 12 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20263057 | 120ml:120mg | Not stated by source | XR06AXY065X001010100548 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20243410 | 120ml:120mg | Not stated by source | XR06AXY065X001010101467 | NHSA |
| Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20263275 | 120ml:120mg | Not stated by source | XR06AXY065X001010105237 | NHSA |
| Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256471 | 120ml:120mg | Not stated by source | XR06AXY065X001010183273 | NHSA |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256167 | 120ml:120mg | Not stated by source | XR06AXY065X001010183644 | NHSA |
| Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264922 | 120ml:120mg | Not stated by source | XR06AXY065X001010183686 | NHSA |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H20255539 | 120ml:0.12g | Not stated by source | XR06AXY065X001010183719 | NHSA |
| Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20243051 | 120ml:120mg | Not stated by source | XR06AXY065X001010183849 | NHSA |
| Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253789 | 120ml:120mg | Not stated by source | XR06AXY065X001010184633 | NHSA |
| Hunan Jin Pu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249219 | 120ml:120mg | Not stated by source | XR06AXY065X001010184673 | NHSA |
| Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264477 | 120ml:120mg | Not stated by source | XR06AXY065X001010184709 | NHSA |
| Fujian Pin Teng Pharma Co., Ltd. romanized | 国药准字H20254099 | 120ml:120mg | Not stated by source | XR06AXY065X001010185084 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 9 filings and 9 distinct first applicants.
Generic 9
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2502684 | Generic | 2025/07/24 | Not stated by source | CDE |
| Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized | CYHS2600749 | Generic | 2026/03/31 | Not stated by source | CDE |
| Nanchang Li Jian Pharma Co., Ltd. romanized | CYHS2602166 | Generic | 2026/08/31 | Not stated by source | CDE |
| Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601012 | Generic | 2026/04/30 | Not stated by source | CDE |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2600909 | Generic | 2026/04/21 | Not stated by source | CDE |
| Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized | CYHS2503982 | Generic | 2025/11/18 | Not stated by source | CDE |
| Chongqing Xi Er An Pharma Co., Ltd. romanized | CYHS2502814 | Generic | 2025/08/05 | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2502291 | Generic | 2025/06/27 | Not stated by source | CDE |
| Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2502258 | Generic | 2025/06/24 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized | CYHS2600749 | Generic | 2026/03/31 | Not stated by source | CDE |
| Nanchang Li Jian Pharma Co., Ltd. romanized | CYHS2602166 | Generic | 2026/08/31 | Not stated by source | CDE |
| Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601012 | Generic | 2026/04/30 | Not stated by source | CDE |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2600909 | Generic | 2026/04/21 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 依巴斯汀 · No verified English name | Jiangsu Jia Yi Pharmaceuticals Co., Ltd. romanized | Y20230001240 | A | Exact ingredient | 2025/05/23 | CDE |
| 依巴斯汀 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20190001098 | A | Exact ingredient | 2025/11/18 | CDE |
| 依巴斯汀 · No verified English name | Yi Ke Lai (Tai Zhou) Pharma Co., Ltd. romanized | Y20190007601 | A | Exact ingredient | 2024/05/22 | CDE |
| 依巴斯汀 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190004079 | A | Exact ingredient | 2025/07/10 | CDE |
| 依巴斯汀 · No verified English name | Bal Pharma Limited | Y20170000264 | A | Exact ingredient | 2024/01/17 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/05No longer listed under review
Jiangxi Xin Zheng Pharma Co., Ltd. romanized
CYHS2501258
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/05 (approval no.: 国药准字H20266447; approval date: 2026/11/03) · NMPA source · row 48
NMPA · Table row 48 ↗ View source ↗ -
2026/11/03Marketing application approved
Jiangxi Xin Zheng Pharma Co., Ltd. romanized
CYHS2501258 · 国药准字H20266447
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 48 ↗ -
2026/08/31Accepted
Nanchang Li Jian Pharma Co., Ltd. romanized
CYHS2602166
Fact date: 2026/08/31 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
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.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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