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Fexofenadine Hydrochloride Oral Suspension

As 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

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

Ingredient cross-list details ↗

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.

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue 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: 4 distinct approval numbers and 4 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized国药准字H20249766120ml: 0.72gNot stated by sourceXR06AXF024X002010100407NHSA
Kui Hua Pharma Group Chongqing Xiao Kui Hua Er Tong Pharmaceutical Co., Ltd. romanized国药准字H20255183120ml:0.72gNot stated by sourceXR06AXF024X002010100972NHSA
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H20266079120ml:0.72gNot stated by sourceXR06AXF024X002010101012NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20254473120ml:0.72gNot stated by sourceXR06AXF024X002010182922NHSA

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: 3 filings and 3 distinct first applicants.

Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS2602547Generic2026/10/14Not stated by sourceCDE
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCYHS2600563Generic2026/02/27Not stated by sourceCDE
Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanizedCYHS2503082Generic2025/08/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS2602547Generic2026/10/14Not stated by sourceCDE
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCYHS2600563Generic2026/02/27Not stated by sourceCDE
API registrations

Non-component matches: 17 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸非索非那定 · No verified English nameM/s. Morepen Laboratories LtdY20240001525IExact ingredient2025/03/05CDE
盐酸非索非那定 · No verified English nameChemeca Drugs Private LimitedY20230000849AExact ingredient2026/10/15CDE
盐酸非索非那定 · No verified English nameVasudha Pharma Chem Ltd.Y20220001219AExact ingredient2025/08/06CDE
盐酸非索非那定 · No verified English nameXian Wan Long Pharmaceutical Co., Ltd. romanizedY20220000912AExact ingredient2024/06/07CDE
盐酸非索非那定 · No verified English nameInd-Swift Laboratories LimitedY20190009263AExact ingredient2023/08/10CDE
盐酸非索非那定 · No verified English nameSynthimed Labs Private LimitedY20190009262AExact ingredient2026/08/11CDE
盐酸非索非那定 · No verified English nameZhejiang Le Pu Pharma Co., Ltd. romanizedY20190007452AExact ingredient2024/02/28CDE
盐酸非索非那定 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20190007370AExact ingredient2023/07/18CDE
盐酸非索非那定 · No verified English nameHainan Sha Ting Ning Pharmaceutical Co., Ltd. romanizedY20190007145AExact ingredient—CDE
盐酸非索非那定 · No verified English nameBeijing Foyou Pharma CO.,LTDY20190007111AExact ingredient2023/03/24CDE
盐酸非索非那定 · No verified English nameWan Te Pharmaceutical (Hainan) Co., Ltd. romanizedY20190006884AExact ingredient2023/03/24CDE
盐酸非索非那定 · No verified English nameSichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanizedY20190006660AExact ingredient—CDE
盐酸非索非那定 · No verified English nameChongqing Zhi En Pharma Co., Ltd. romanizedY20190006653AExact ingredient—CDE
盐酸非索非那定 · No verified English nameChi Zhou Dong Sheng Pharma Co., Ltd. romanizedY20190006585AExact ingredient2026/04/20CDE
盐酸非索非那定 · No verified English nameJiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedY20190006077AExact ingredient2025/08/22CDE
盐酸非索非那定 · No verified English nameJiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190004696AExact ingredient2025/08/01CDE
盐酸非索非那定 · No verified English nameTai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanizedY20190004565AExact ingredient2025/02/06CDE
盐酸非索非那定 · No verified English nameVirupaksha Organics LtdY20170000127AExact ingredient2026/08/07CDE

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.

  1. 2026/10/20Marketing application approved

    Ou Bi Le Health Technology (Shanghai) Co., Ltd. romanized

    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 ↗
  2. 2026/10/20Marketing application approved

    Ou Bi Le Health Technology (Shanghai) Co., Ltd. romanized

    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 ↗
  3. 2026/10/20Marketing application approved

    Ou Bi Le Health Technology (Shanghai) Co., Ltd. romanized

    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 ↗
  4. 2026/10/20Marketing application approved

    Ou Bi Le Health Technology (Shanghai) Co., Ltd. romanized

    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 ↗
  5. 2026/10/14Accepted

    Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized

    CYHS2602547

    Fact date: 2026/10/14 · 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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