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Propranolol hydrochloride oral solution

Matched
Active ingredients (original)
PROPRANOLOL HYDROCHLORIDE
Dosage form (original)
SOLUTION
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 approval1987/05/15
ANDA applications4
RLD applicantETON PHARMACEUTICALS INC

Currently marketed products: 4 · 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
A070690-001PROPRANOLOL HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 40MG/5ML1987/05/15N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A070690-002PROPRANOLOL HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 20MG/5ML1987/05/15N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A071984-001PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 20MG/5ML1989/03/03N / NDISCONTINUEDopenFDA ↗
A071985-001PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 40MG/5ML1989/03/03N / NDISCONTINUEDopenFDA ↗
A219165-001PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS LLCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 20MG/5ML2026/06/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N205410-001HEMANGEOLETON PHARMACEUTICALS INCSOLUTIONORALPROPRANOLOL HYDROCHLORIDE: 4.28MG/ML2014/03/14Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗

Listed US patents

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

Latest listed patent expiration2028/10/16
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
N205410-00183384892028/10/16— / —U-1496—openFDA ↗
N205410-00189872622028/10/16— / —U-1988—openFDA ↗

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: 2027/02/15

Application / product numberExclusivity codeListed expirationOfficial source
A219165-001CGT2027/02/15openFDA ↗

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 2

Company (original)Identifier (original)Source dateOfficial source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized国药准字H20213648See source—Official source ↗
Wuhan Ke Fu Xin Yao Co., Ltd. romanized国药准字H20213549See source—Official source ↗
Wuhan Ke Fu Xin Yao Co., Ltd. romanized国药准字H20213549See source—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS26014492026/06/18Official source ↗
Shenyang Tian Bang Pharma Co., Ltd. romanizedCYHS26025522026/10/16Official source ↗
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS26025382026/10/14Official source ↗
Hubei Min Kang Pharmaceutical Co., Ltd. romanizedCYHS25016502025/05/08Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS26014492026/06/18Official source ↗
Shenyang Tian Bang Pharma Co., Ltd. romanizedCYHS26025522026/10/16Official source ↗
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS26025382026/10/14Official source ↗
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS26014272026/06/16Official source ↗

API companies with A status 14

Company (original)Identifier (original)Source dateOfficial source
Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanizedY202500000942026/07/13Official source ↗
Hebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY202400011442026/02/13Official source ↗
COSMA S.P.A.Y202400006772026/09/10Official source ↗
TIANJIN LISHENG PHARMACEUTICAL CO., LTDY202300001532026/01/07Official source ↗
Nei Menggu Kang Pu Pharma Co., Ltd. romanizedY202200008042024/04/09Official source ↗
Yun Peng Pharmaceuticals Group Co., Ltd. romanizedY202100012422026/08/28Official source ↗
Changzhou Shi Tian Hua Pharmaceutical Co., Ltd. romanizedY20190009782—Official source ↗
Changzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY201900096862025/05/30Official source ↗
Ya Bao Pharma Group Co., Ltd. romanizedY201900096222025/07/28Official source ↗
Jiangsu Yun Yang Group Pharma Co., Ltd. romanizedY201900049802025/08/23Official source ↗
Hubei Cheng Tian Pharma Co., Ltd. romanizedY201800012092026/05/27Official source ↗
Changzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20180000739—Official source ↗
IPCA LABORATORIES LIMITEDY201700018502025/03/29Official source ↗
Hua Zhong Pharma Co., Ltd. romanizedY201700014282024/10/18Official source ↗
Changzhou Kang Pu Pharma Co., Ltd. romanizedY201700010182023/07/14Official 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 SOLUTION / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-028. Chinese Pharmacopoeia general chapter 0123

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

Name and dosage-form matching sources