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Sign in to subscribeAs of 13 November 2026, for Fexofenadine Hydrochloride Oral Suspension, 3 applications are listed as under review at China's CDE; 2 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.
Listed in the US FDA Orange Book as CHILDREN'S ALLEGRA ALLERGY (NDA 201373, CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE).
Last 90 days: Marketing application approved: 4 applicationsAccepted: 1 application
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 5 of 5 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Oral Suspension. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| CHILDREN'S ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 201373 · Product no. 001 | SUSPENSION | ORAL | HUMAN OTC DRUG | 2011/01/24 |
| ALLEGRA | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 021963 · Product no. 001 | SUSPENSION | ORAL | DISCONTINUED | 2006/10/16 |
| CHILDREN'S ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 201373 · Product no. 002 | SUSPENSION | ORAL | DISCONTINUED | 2011/01/24 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020872 · Product no. 007, 010 | TABLET | ORAL | HUMAN OTC DRUG | 2011/01/24 |
| ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020872 · Product no. 009 | TABLET | ORAL | HUMAN OTC DRUG | 2011/01/24 |
| ALLEGRA | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020625 · Product no. 001 | CAPSULE | ORAL | DISCONTINUED | 1996/07/25 |
| ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020872 · Product no. 008 | TABLET | ORAL | DISCONTINUED | 2011/01/24 |
| CHILDREN'S ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020872 · Product no. 005 | TABLET | ORAL | DISCONTINUED | 2011/01/24 |
| CHILDREN'S ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 021909 · Product no. 002 | TABLET, ORALLY DISINTEGRATING | ORAL | DISCONTINUED | 2011/01/24 |
| CHILDREN'S ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 020872 · Product no. 006 | TABLET | ORAL | DISCONTINUED | 2011/01/24 |
| CHILDREN'S ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | NDA 021909 · Product no. 003 | TABLET, ORALLY DISINTEGRATING | ORAL | DISCONTINUED | 2011/01/24 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
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.
Loaded records: 4 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20249766 | 120ml: 0.72g | Not stated by source | XR06AXF024X002010100407 | NHSA |
| Kui Hua Pharma Group Chongqing Xiao Kui Hua Er Tong Pharmaceutical Co., Ltd. romanized | 国药准字H20255183 | 120ml:0.72g | Not stated by source | XR06AXF024X002010100972 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20266079 | 120ml:0.72g | Not stated by source | XR06AXF024X002010101012 | NHSA |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20254473 | 120ml:0.72g | Not stated by source | XR06AXF024X002010182922 | 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.
Loaded records: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized | CYHS2602547 | Generic | 2026/10/14 | Not stated by source | CDE |
| Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CYHS2600563 | Generic | 2026/02/27 | Not stated by source | CDE |
| Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized | CYHS2503082 | Generic | 2025/08/22 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized | CYHS2602547 | Generic | 2026/10/14 | Not stated by source | CDE |
| Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CYHS2600563 | Generic | 2026/02/27 | Not stated by source | CDE |
Non-component matches: 17 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 盐酸非索非那定 · No verified English name | M/s. Morepen Laboratories Ltd | Y20240001525 | I | Exact ingredient | 2025/03/05 | CDE |
| 盐酸非索非那定 · No verified English name | Chemeca Drugs Private Limited | Y20230000849 | A | Exact ingredient | 2026/10/15 | CDE |
| 盐酸非索非那定 · No verified English name | Vasudha Pharma Chem Ltd. | Y20220001219 | A | Exact ingredient | 2025/08/06 | CDE |
| 盐酸非索非那定 · No verified English name | Xian Wan Long Pharmaceutical Co., Ltd. romanized | Y20220000912 | A | Exact ingredient | 2024/06/07 | CDE |
| 盐酸非索非那定 · No verified English name | Ind-Swift Laboratories Limited | Y20190009263 | A | Exact ingredient | 2023/08/10 | CDE |
| 盐酸非索非那定 · No verified English name | Synthimed Labs Private Limited | Y20190009262 | A | Exact ingredient | 2026/08/11 | CDE |
| 盐酸非索非那定 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20190007452 | A | Exact ingredient | 2024/02/28 | CDE |
| 盐酸非索非那定 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190007370 | A | Exact ingredient | 2023/07/18 | CDE |
| 盐酸非索非那定 · No verified English name | Hainan Sha Ting Ning Pharmaceutical Co., Ltd. romanized | Y20190007145 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20190007111 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸非索非那定 · No verified English name | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190006884 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸非索非那定 · No verified English name | Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | Y20190006660 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 · No verified English name | Chongqing Zhi En Pharma Co., Ltd. romanized | Y20190006653 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 · No verified English name | Chi Zhou Dong Sheng Pharma Co., Ltd. romanized | Y20190006585 | A | Exact ingredient | 2026/04/20 | CDE |
| 盐酸非索非那定 · No verified English name | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | Y20190006077 | A | Exact ingredient | 2025/08/22 | CDE |
| 盐酸非索非那定 · No verified English name | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004696 | A | Exact ingredient | 2025/08/01 | CDE |
| 盐酸非索非那定 · No verified English name | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | Y20190004565 | A | Exact ingredient | 2025/02/06 | CDE |
| 盐酸非索非那定 · No verified English name | Virupaksha Organics Ltd | Y20170000127 | A | Exact ingredient | 2026/08/07 | 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.
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.
JXHS2500028 · 国药准字HJ20260091
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 105 ↗JXHS2500027 · 国药准字HJ20260090
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 104 ↗JXHS2500021 · 国药准字HJ20260091
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 103 ↗JXHS2500020 · 国药准字HJ20260090
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 102 ↗CYHS2602547
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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