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As of 13 November 2026, for Amiodarone Hydrochloride Tablets, 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 3 holders.
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
Current coverage may be incomplete
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 2 of 2 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 name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| CORDARONE | WYETH PHARMACEUTICALS LLC | NDA 018972 · Product no. 001 | TABLET | ORAL | DISCONTINUED | 1985/12/24 |
Other dosage forms of the same ingredient
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| NEXTERONE | BAXTER HEALTHCARE CORP | NDA 022325 · Product no. 002, 003 | INJECTABLE | INJECTION | HUMAN PRESCRIPTION DRUG | 2010/11/16 |
| CORDARONE | WYETH PHARMACEUTICALS INC | NDA 020377 · Product no. 001 | INJECTABLE | INJECTION | DISCONTINUED | 1995/08/03 |
| NEXTERONE | BAXTER HEALTHCARE CORP | NDA 022325 · Product no. 001 | INJECTABLE | INJECTION | DISCONTINUED | 2008/12/24 |
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.
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.
Catalogue holders3View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers17View records ↓
API companies with A status8View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31021872 | 2022/02/14 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 2020/09/25 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H33020581 | 2020/05/11 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
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: 17 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Jia Lin Pharma Co., Ltd. romanized | 国药准字H20003843 | 0.2g | Category A | XC01BDA201A001010100056 | NHSA |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H44021623 | 0.2g | Category A | XC01BDA201A001010100269 | NHSA |
| Guangdong Hua Nan Pharma Group Co., Ltd. romanized | 国药准字H44020694 | 0.2g | Category A | XC01BDA201A001010100290 | NHSA |
| San Cai Shi Qi Pharmaceutical Co., Ltd. romanized | 国药准字H44023284 | 0.2g | Category A | XC01BDA201A001010100322 | NHSA |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H44025075 | 0.1g | Category A | XC01BDA201A001010100376 | NHSA |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31021872 | 0.2g | Category A | XC01BDA201A001010100818 | NHSA |
| Jiangsu Lian Shui Pharmaceutical Co., Ltd. romanized | 国药准字H32022397 | 0.2g | Category A | XC01BDA201A001010101466 | NHSA |
| Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized | 国药准字H32024405 | 0.2g | Category A | XC01BDA201A001010101529 | NHSA |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | 国药准字H32024766 | 0.2g | Category A | XC01BDA201A001010101631 | NHSA |
| Jiangsu En Hua Sai De Pharma Co., Ltd. romanized | 国药准字H32021922 | 0.2g | Category A | XC01BDA201A001010101721 | NHSA |
| Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Yi Factory romanized | 国药准字H41021027 | 0.2g | Category A | XC01BDA201A001010103012 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41021592 | 0.2g | Category A | XC01BDA201A001010103098 | NHSA |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 0.2g | Category A | XC01BDA201A001010104165 | NHSA |
| Sai Nuo Fei (Hangzhou) Pharmaceutical Co., Ltd. romanized | 国药准字H19993254 | 0.2g | Category A | XC01BDA201A001010104502 | NHSA |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized | 国药准字H33020581 | 0.2g | Category A | XC01BDA201A001010104554 | NHSA |
| Sanofi Winthrop Industrie | 国药准字HJ20181050 | See source | Category A | XC01BDA201A001010178821 | NHSA |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31021872 | 0.2g | Category A | XC01BDA201A001010200818 | NHSA |
| Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Yi Factory romanized | 国药准字H41021027 | 0.2g | Category A | XC01BDA201A001010203012 | NHSA |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 0.2g | Category A | XC01BDA201A001010204165 | NHSA |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized | 国药准字H33020581 | 0.2g | Category A | XC01BDA201A001010204554 | NHSA |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 0.2g | Category A | XC01BDA201A001010304165 | NHSA |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 0.2g | Category A | XC01BDA201A001010404165 | NHSA |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 0.2g | Category A | XC01BDA201A001010504165 | NHSA |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H44021436 | 0.2g | Category A | XC01BDA201A001020100376 | NHSA |
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 2 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601549 | Generic | 2026/07/01 | Not stated by source | CDE |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601548 | Generic | 2026/07/01 | Not stated by source | CDE |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2600788 | Generic | 2026/04/08 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601549 | Generic | 2026/07/01 | Not stated by source | CDE |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2601548 | Generic | 2026/07/01 | Not stated by source | CDE |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2600788 | Generic | 2026/04/08 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸胺碘酮 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250000128 | I | Exact ingredient | 2025/02/07 | CDE |
| 盐酸胺碘酮 · No verified English name | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20240000433 | A | Exact ingredient | 2026/04/21 | CDE |
| 盐酸胺碘酮 · No verified English name | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized | Y20220001071 | A | Exact ingredient | 2026/08/28 | CDE |
| 盐酸胺碘酮 · No verified English name | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20210001090 | A | Exact ingredient | 2026/06/02 | CDE |
| 盐酸胺碘酮 · No verified English name | Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20210000139 | A | Exact ingredient | 2023/08/26 | CDE |
| 盐酸胺碘酮 · No verified English name | Sanofi Chimie | Y20190009089 | A | Exact ingredient | 2025/03/25 | CDE |
| 盐酸胺碘酮 · No verified English name | Zhejiang Heng Kang Pharma Co., Ltd. romanized | Y20190007055 | A | Exact ingredient | 2025/05/01 | CDE |
| 盐酸胺碘酮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002029 | A | Exact ingredient | 2025/02/12 | CDE |
| 盐酸胺碘酮 · No verified English name | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | Y20190000397 | A | Exact ingredient | 2025/05/13 | CDE |
| 盐酸胺碘酮 · No verified English name | Sanofi Chimie | Y20180000626 | I | Exact ingredient | 2018/08/30 | CDE |
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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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