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Fexofenadine Hydrochloride Oral Suspension

Matched
Active ingredients (original)
FEXOFENADINE HYDROCHLORIDE
Dosage form (original)
SUSPENSION
Route (original)
ORAL

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “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.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. 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 approval2006/10/16
ANDA applications4
RLD applicantCHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

Currently marketed products: 6 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A201311-001FEXOFENADINE HYDROCHLORIDEP AND L DEVELOPMENT LLCSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2012/07/25N / NDISCONTINUEDopenFDA ↗
A203330-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYP AND L DEVELOPMENT LLCSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2014/11/18N / NHUMAN OTC DRUGopenFDA ↗
A203330-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESP AND L DEVELOPMENT LLCSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2014/11/18N / YHUMAN OTC DRUGopenFDA ↗
A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYTARO PHARMACEUTICAL INDUSTRIES LTDSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2017/11/09N / NHUMAN OTC DRUGopenFDA ↗
A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESTARO PHARMACEUTICAL INDUSTRIES LTDSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2017/11/09N / NHUMAN OTC DRUGopenFDA ↗
A213466-001FEXOFENADINE HYDROCHLORIDEAUROBINDO PHARMA LTDSUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2023/05/23N / NHUMAN OTC DRUGopenFDA ↗
N021963-001ALLEGRACHATTEM INC DBA SANOFI CONSUMER HEALTHCARESUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2006/10/16Y / NDISCONTINUEDopenFDA ↗
N201373-001CHILDREN'S ALLEGRA ALLERGYCHATTEM INC DBA SANOFI CONSUMER HEALTHCARESUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML2011/01/24Y / YHUMAN OTC DRUGopenFDA ↗
N201373-002CHILDREN'S ALLEGRA HIVESCHATTEM INC DBA SANOFI CONSUMER HEALTHCARESUSPENSIONORALFEXOFENADINE HYDROCHLORIDE: 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2011/01/24Y / NDISCONTINUEDopenFDA ↗

Listed US patents

*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.

Latest listed patent expiration2030/08/02
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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
N201373-00189330972030/08/02— / Y——openFDA ↗
N201373-00289330972030/08/02— / Y——openFDA ↗

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial 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 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

NHSA approval numbers 4

Company (original)Identifier (original)Source dateOfficial source
Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized国药准字H20249766120ml: 0.72g—Official source ↗
Kui Hua Pharma Group Chongqing Xiao Kui Hua Er Tong Pharmaceutical Co., Ltd. romanized国药准字H20255183120ml:0.72g—Official source ↗
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H20266079120ml:0.72g—Official source ↗
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20254473120ml:0.72g—Official source ↗

Under review 3

Company (original)Identifier (original)Source dateOfficial source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS26025472026/10/14Official source ↗
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCYHS26005632026/02/27Official source ↗
Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanizedCYHS25030822025/08/22Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS26025472026/10/14Official source ↗
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCYHS26005632026/02/27Official source ↗

API companies with A status 17

Company (original)Identifier (original)Source dateOfficial source
Chemeca Drugs Private LimitedY202300008492026/10/15Official source ↗
Vasudha Pharma Chem Ltd.Y202200012192025/08/06Official source ↗
Xian Wan Long Pharmaceutical Co., Ltd. romanizedY202200009122024/06/07Official source ↗
Ind-Swift Laboratories LimitedY201900092632023/08/10Official source ↗
Synthimed Labs Private LimitedY201900092622026/08/11Official source ↗
Zhejiang Le Pu Pharma Co., Ltd. romanizedY201900074522024/02/28Official source ↗
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y201900073702023/07/18Official source ↗
Hainan Sha Ting Ning Pharmaceutical Co., Ltd. romanizedY20190007145—Official source ↗
Beijing Foyou Pharma CO.,LTDY201900071112023/03/24Official source ↗
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanizedY201900068842023/03/24Official source ↗
Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanizedY20190006660—Official source ↗
Chongqing Zhi En Pharma Co., Ltd. romanizedY20190006653—Official source ↗
Chi Zhou Dong Sheng Pharma Co., Ltd. romanizedY201900065852026/04/20Official source ↗
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedY201900060772025/08/22Official source ↗
Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY201900046962025/08/01Official source ↗
Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanizedY201900045652025/02/06Official source ↗
Virupaksha Organics LtdY201700001272026/08/07Official 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 SUSPENSION / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-030. Chinese Pharmacopoeia general chapter 0123

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources