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Amiodarone Hydrochloride Tablets

Matched
Active ingredients (original)
AMIODARONE HYDROCHLORIDE
Dosage form (original)
TABLET
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 approval1985/12/24
ANDA applications13
RLD applicantWYETH PHARMACEUTICALS LLC

Currently marketed products: 20 · 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
A074739-001AMIODARONE HYDROCHLORIDETEVA PHARMACEUTICALS USATABLETORALAMIODARONE HYDROCHLORIDE: 200MG1998/11/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A074895-001AMIODARONE HYDROCHLORIDETEVA PHARMACEUTICALS USA INCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG1999/04/16N / NDISCONTINUEDopenFDA ↗
A075135-001PACERONEUPSHER SMITH LABORATORIES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG1998/04/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075135-002PACERONEUPSHER SMITH LABORATORIES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 100MG2005/04/12N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075135-003PACERONEUPSHER SMITH LABORATORIES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2020/07/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075188-001AMIODARONE HYDROCHLORIDEPHARMOBEDIENT CONSULTING LLCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG1999/02/24N / NDISCONTINUEDopenFDA ↗
A075315-001AMIODARONE HYDROCHLORIDEUPSHER SMITH LABORATORIES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG1998/12/23N / NDISCONTINUEDopenFDA ↗
A075315-002AMIODARONE HYDROCHLORIDEUPSHER SMITH LABORATORIES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2000/06/30N / NDISCONTINUEDopenFDA ↗
A075389-001AMIODARONE HYDROCHLORIDEDR REDDYS LABORATORIES SATABLETORALAMIODARONE HYDROCHLORIDE: 200MG2001/01/25N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075389-002AMIODARONE HYDROCHLORIDEDR REDDYS LABORATORIES SATABLETORALAMIODARONE HYDROCHLORIDE: 100MG2017/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075389-003AMIODARONE HYDROCHLORIDEDR REDDYS LABORATORIES SATABLETORALAMIODARONE HYDROCHLORIDE: 400MG2017/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075424-001AMIODARONE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTDTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2001/03/30N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A075424-002AMIODARONE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTDTABLETORALAMIODARONE HYDROCHLORIDE: 100MG2002/12/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A076362-001AMIODARONE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTDTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2002/11/29N / NDISCONTINUEDopenFDA ↗
A076362-002AMIODARONE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTDTABLETORALAMIODARONE HYDROCHLORIDE: 300MG2003/12/02N / NDISCONTINUEDopenFDA ↗
A077069-001AMIODARONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2005/04/08N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077069-002AMIODARONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2005/04/08N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A077069-003AMIODARONE HYDROCHLORIDECHARTWELL RX SCIENCES LLCTABLETORALAMIODARONE HYDROCHLORIDE: 100MG2016/10/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A078578-001AMIODARONE HYDROCHLORIDERUBICON RESEARCH LTDTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2008/11/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A078578-002AMIODARONE HYDROCHLORIDERUBICON RESEARCH LTDTABLETORALAMIODARONE HYDROCHLORIDE: 100MG2021/02/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A078578-003AMIODARONE HYDROCHLORIDERUBICON RESEARCH LTDTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2021/02/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A079029-001AMIODARONE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2008/09/16N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A079029-002AMIODARONE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INCTABLETORALAMIODARONE HYDROCHLORIDE: 100MG2023/01/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A079029-003AMIODARONE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INCTABLETORALAMIODARONE HYDROCHLORIDE: 400MG2023/01/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204742-001AMIODARONE HYDROCHLORIDEAUROBINDO PHARMA LTDTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2016/06/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A213446-001AMIODARONE HYDROCHLORIDEUNICHEM LABORATORIES LTDTABLETORALAMIODARONE HYDROCHLORIDE: 200MG2020/07/21N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N018972-001CORDARONEWYETH PHARMACEUTICALS LLCTABLETORALAMIODARONE HYDROCHLORIDE: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1985/12/24Y / NDISCONTINUEDopenFDA ↗

Listed US patents

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

Latest listed patent expiration—
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
Not listed

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 3

Company (original)Identifier (original)Source dateOfficial source
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized国药准字H310218720.2g2022/02/14Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g2020/09/25Official source ↗
Ningbo Da Hong Ying Pharma Co., Ltd. romanized国药准字H330205810.2g2020/05/11Official source ↗

NHSA approval numbers 17

Company (original)Identifier (original)Source dateOfficial source
Beijing Jia Lin Pharma Co., Ltd. romanized国药准字H200038430.2g—Official source ↗
Guangdong Bi Di Pharma Co., Ltd. romanized国药准字H440216230.2g—Official source ↗
Guangdong Hua Nan Pharma Group Co., Ltd. romanized国药准字H440206940.2g—Official source ↗
San Cai Shi Qi Pharmaceutical Co., Ltd. romanized国药准字H440232840.2g—Official source ↗
Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized国药准字H440250750.1g—Official source ↗
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized国药准字H310218720.2g—Official source ↗
Jiangsu Lian Shui Pharmaceutical Co., Ltd. romanized国药准字H320223970.2g—Official source ↗
Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized国药准字H320244050.2g—Official source ↗
Jiangsu Yue Xing Pharma Co., Ltd. romanized国药准字H320247660.2g—Official source ↗
Jiangsu En Hua Sai De Pharma Co., Ltd. romanized国药准字H320219220.2g—Official source ↗
Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Yi Factory romanized国药准字H410210270.2g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H410215920.2g—Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g—Official source ↗
Sai Nuo Fei (Hangzhou) Pharmaceutical Co., Ltd. romanized国药准字H199932540.2g—Official source ↗
Hangzhou Huang Sen Bio Technology Co., Ltd. romanized国药准字H330205810.2g—Official source ↗
Sanofi Winthrop Industrie国药准字HJ20181050See source—Official source ↗
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized国药准字H310218720.2g—Official source ↗
Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Yi Factory romanized国药准字H410210270.2g—Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g—Official source ↗
Hangzhou Huang Sen Bio Technology Co., Ltd. romanized国药准字H330205810.2g—Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g—Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g—Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214560.2g—Official source ↗
Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized国药准字H440214360.2g—Official source ↗

Under review 3

Company (original)Identifier (original)Source dateOfficial source
Shanghai Li Xiang Pharmaceutical Co., Ltd. romanizedCYHS26015492026/07/01Official source ↗
Shanghai Li Xiang Pharmaceutical Co., Ltd. romanizedCYHS26015482026/07/01Official source ↗
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanizedCYHS26007882026/04/08Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Shanghai Li Xiang Pharmaceutical Co., Ltd. romanizedCYHS26015492026/07/01Official source ↗
Shanghai Li Xiang Pharmaceutical Co., Ltd. romanizedCYHS26015482026/07/01Official source ↗
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanizedCYHS26007882026/04/08Official source ↗

API companies with A status 8

Company (original)Identifier (original)Source dateOfficial source
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY202400004332026/04/21Official source ↗
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY202200010712026/08/28Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedY202100010902026/06/02Official source ↗
Shandong Fang Ming Pharma Group Co., Ltd. romanizedY202100001392023/08/26Official source ↗
Sanofi ChimieY201900090892025/03/25Official source ↗
Zhejiang Heng Kang Pharma Co., Ltd. romanizedY201900070552025/05/01Official source ↗
Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedY201900020292025/02/12Official source ↗
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanizedY201900003972025/05/13Official 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.

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

Name and dosage-form matching sources