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Fexofenadine Hydrochloride Tablets

As of 13 November 2026, for Fexofenadine Hydrochloride Tablets, 10 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as ALLEGRA ALLERGY (NDA 020872, CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE).

Last 90 days: Accepted: 4 applications

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: Tablets. 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
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 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 HIVES CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE NDA 020872 · Product no. 006 TABLET 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
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 020625 · Product no. 001 CAPSULE ORAL DISCONTINUED 1996/07/25
ALLEGRA CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE NDA 021963 · Product no. 001 SUSPENSION ORAL DISCONTINUED 2006/10/16
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 021909 · Product no. 003 TABLET, ORALLY DISINTEGRATING ORAL DISCONTINUED 2011/01/24
CHILDREN'S ALLEGRA HIVES CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE NDA 201373 · Product no. 002 SUSPENSION 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: 4 holders; 4 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
Zhejiang Wan Cheng Pharma Co., Ltd. romanizedZhejiang Wan Cheng Pharma Co., Ltd. romanized国药准字H200601492024/01/1160mgDrug that passed quality-and-efficacy consistency evaluationCDE
Zhejiang Wan Cheng Pharma Co., Ltd. romanizedZhejiang Wan Cheng Pharma Co., Ltd. romanized国药准字H200601502024/01/1130mgDrug that passed quality-and-efficacy consistency evaluationCDE
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanizedSichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized国药准字H200701242023/09/2060mgDrug that passed quality-and-efficacy consistency evaluationCDE
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanizedChengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H201532212021/11/2960mgDrug that passed quality-and-efficacy consistency evaluationCDE
Xian Wan Long Pharmaceutical Co., Ltd. romanizedXian Wan Long Pharmaceutical Co., Ltd. romanized国药准字H200807102021/01/1560mgDrug that passed quality-and-efficacy consistency evaluationCDE

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: 16 distinct approval numbers and 11 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Foyou Pharma CO.,LTD国药准字H2013004060mgNot stated by sourceXR06AXF024A001010100177NHSA
Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized国药准字H2006033060mgNot stated by sourceXR06AXF024A001010100973NHSA
Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized国药准字H20080437120mgNot stated by sourceXR06AXF024A001010101016NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ20170079120mgNot stated by sourceXR06AXF024A001010101533NHSA
Xian Wan Long Pharmaceutical Co., Ltd. romanized国药准字H2008071060mgNot stated by sourceXR06AXF024A001010102525NHSA
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized国药准字H2007012460mgNot stated by sourceXR06AXF024A001010104065NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006015030mgNot stated by sourceXR06AXF024A001010104726NHSA
Yunnan Yu Feng Pharma Co., Ltd. romanized国药准字H2008012330mgNot stated by sourceXR06AXF024A001010105710NHSA
OPELLA HEALTHCARE FRANCE SAS国药准字HJ20210012180mgNot stated by sourceXR06AXF024A001010178821NHSA
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H2015322160mgNot stated by sourceXR06AXF024A001010180435NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2013004060mgNot stated by sourceXR06AXF024A001010200177NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ20170079120mgNot stated by sourceXR06AXF024A001010201533NHSA
Xian Wan Long Pharmaceutical Co., Ltd. romanized国药准字H2008071060mgNot stated by sourceXR06AXF024A001010202525NHSA
Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized国药准字H2009033360mgNot stated by sourceXR06AXF024A001010203795NHSA
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized国药准字H2007012460mgNot stated by sourceXR06AXF024A001010204065NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006015030mgNot stated by sourceXR06AXF024A001010204726NHSA
Yunnan Yu Feng Pharma Co., Ltd. romanized国药准字H2008012330mgNot stated by sourceXR06AXF024A001010205710NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010278770NHSA
OPELLA HEALTHCARE FRANCE SAS国药准字HJ20210012180mgNot stated by sourceXR06AXF024A001010278821NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2013004060mgNot stated by sourceXR06AXF024A001010300177NHSA
Xian Wan Long Pharmaceutical Co., Ltd. romanized国药准字H2008071060mgNot stated by sourceXR06AXF024A001010302525NHSA
Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized国药准字H2009033360mgNot stated by sourceXR06AXF024A001010303795NHSA
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized国药准字H2007012460mgNot stated by sourceXR06AXF024A001010304065NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006015030mgNot stated by sourceXR06AXF024A001010304726NHSA
Yunnan Yu Feng Pharma Co., Ltd. romanized国药准字H2008012330mgNot stated by sourceXR06AXF024A001010305710NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010378770NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2013004060mgNot stated by sourceXR06AXF024A001010400177NHSA
Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized国药准字H2009033360mgNot stated by sourceXR06AXF024A001010403795NHSA
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized国药准字H2007012460mgNot stated by sourceXR06AXF024A001010404065NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006015030mgNot stated by sourceXR06AXF024A001010404726NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010478770NHSA
Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized国药准字H2009033360mgNot stated by sourceXR06AXF024A001010503795NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010578770NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010778770NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ2017007760mgNot stated by sourceXR06AXF024A001010878770NHSA
Sun Pharmaceutical Industries Ltd.国药准字J2017003560mgNot stated by sourceXR06AXF024A001020101533NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006014960mgNot stated by sourceXR06AXF024A001020104726NHSA
Sun Pharmaceutical Industries Ltd.H20170079120mgNot stated by sourceXR06AXF024A001020178770NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006014960mgNot stated by sourceXR06AXF024A001020204726NHSA
Sun Pharmaceutical Industries Ltd.H20170079120mgNot stated by sourceXR06AXF024A001020278770NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006014960mgNot stated by sourceXR06AXF024A001020304726NHSA
Sun Pharmaceutical Industries Ltd.国药准字HJ20170080120mgNot stated by sourceXR06AXF024A001020378770NHSA
Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized国药准字H2006014960mgNot stated by sourceXR06AXF024A001020404726NHSA

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: 10 filings and 4 distinct first applicants.

Import re-registration 2 · Generic 8

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
SUN PHARMACEUTICAL INDUSTRIES LIMITEDJYHZ2600273Import re-registration2026/10/21Not stated by sourceCDE
SUN PHARMACEUTICAL INDUSTRIES LIMITEDJYHZ2600272Import re-registration2026/10/21Not stated by sourceCDE
Hefei He Yuan Pharma Co., Ltd. romanizedCYHS2602222Generic2026/09/07Not stated by sourceCDE
Hefei He Yuan Pharma Co., Ltd. romanizedCYHS2602220Generic2026/09/07Not stated by sourceCDE
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanizedCYHS2601983Generic2026/08/12Not stated by sourceCDE
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanizedCYHS2601982Generic2026/08/12Not stated by sourceCDE
Zhi En Bio Technology Co., Ltd. romanizedCYHS2503071Generic2025/08/21Not stated by sourceCDE
Zhi En Bio Technology Co., Ltd. romanizedCYHS2503070Generic2025/08/21Not stated by sourceCDE
Zhi En Bio Technology Co., Ltd. romanizedCYHS2503069Generic2025/08/21Not stated by sourceCDE
Zhi En Bio Technology Co., Ltd. romanizedCYHS2503068Generic2025/08/21Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei He Yuan Pharma Co., Ltd. romanizedCYHS2602222Generic2026/09/07Not stated by sourceCDE
Hefei He Yuan Pharma Co., Ltd. romanizedCYHS2602220Generic2026/09/07Not stated by sourceCDE
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanizedCYHS2601983Generic2026/08/12Not stated by sourceCDE
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanizedCYHS2601982Generic2026/08/12Not 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. 2026/10/21Accepted

    SUN PHARMACEUTICAL INDUSTRIES LIMITED

    JYHZ2600273

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/10/21Accepted

    SUN PHARMACEUTICAL INDUSTRIES LIMITED

    JYHZ2600272

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/09/07Accepted

    Hefei He Yuan Pharma Co., Ltd. romanized

    CYHS2602222

    Fact date: 2026/09/07 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/09/07Accepted

    Hefei He Yuan Pharma Co., Ltd. romanized

    CYHS2602220

    Fact date: 2026/09/07 · 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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