Monthly
US$200
Billed every month
Isosorbide Mononitrate Extended-Release Tablets(单硝酸异山梨酯缓释片)
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: 2026/11/10 07:27
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders10View records ↓
Under-review filings5View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers21View records ↓
API companies with A status14View records ↓
Chemical-drug catalogue
Loaded records: 10 holders; 6 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 南京华兴医药科技有限公司 | 湖北荆江源制药股份有限公司 | 国药准字H20264264 | 2026/05/07 | 40mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 鲁南制药集团股份有限公司 | 鲁南贝特制药有限公司 | 国药准字H20249678 | 2024/12/06 | 40mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南京易亨制药有限公司 | 南京易亨制药有限公司 | 国药准字H20249430 | 2024/11/22 | 40mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 西藏诺迪康科技发展有限公司 | 阿斯利康制药有限公司 | 国药准字H20030418 | 2024/09/24 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 西藏诺迪康科技发展有限公司 | 阿斯利康制药有限公司 | 国药准字H20030417 | 2024/09/24 | 30mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 山东力诺制药有限公司 | 山东力诺制药有限公司 | 国药准字H19991115 | 2022/10/14 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 山东鲁抗医药集团赛特有限责任公司 | 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 2022/07/04 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 鲁南贝特制药有限公司 | 鲁南贝特制药有限公司 | 国药准字H19991039 | 2021/05/07 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 乐普药业股份有限公司 | 乐普药业股份有限公司 | 国药准字H20066203 | 2021/02/09 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20066717 | 2020/07/07 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20066716 | 2020/07/07 | 30mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 阿斯利康制药有限公司 | 国药准字H20030418 | 1999/03/17 | 60mg | Other drug (其他药品) | CDE |
| — | 阿斯利康制药有限公司 | 国药准字H20030417 | 1999/03/17 | 30mg | Other drug (其他药品) | 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: 21 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 华润双鹤药业股份有限公司 | 国药准字H10980298 | 50mg | Category B (乙) | XC01DAD024A010010100144 | NHSA |
| 上海世康特制药有限公司 | 国药准字H19990308 | 60mg | Category B (乙) | XC01DAD024A010010100760 | NHSA |
| 上海新亚药业闵行有限公司 | 国药准字H20010005 | 40mg | Category B (乙) | XC01DAD024A010010100795 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010643 | 40mg | Category B (乙) | XC01DAD024A010010100804 | NHSA |
| 爱施健(广东)制药有限公司 | 国药准字H10980015 | 60mg | Category B (乙) | XC01DAD024A010010100863 | NHSA |
| 西藏诺迪康科技发展有限公司 | 国药准字H20030417 | 30mg | Category B (乙) | XC01DAD024A010010101359 | NHSA |
| 南京臣功制药股份有限公司 | 国药准字H20010247 | 60mg | Category B (乙) | XC01DAD024A010010101556 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20249430 | 40mg | Category B (乙) | XC01DAD024A010010101605 | NHSA |
| 乐声药业石家庄有限公司 | 国药准字H20020266 | 50mg | Category B (乙) | XC01DAD024A010010102680 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20113427 | 30mg | Category B (乙) | XC01DAD024A010010102987 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20066203 | 40mg | Category B (乙) | XC01DAD024A010010103094 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010104012 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20066716 | 30mg | Category B (乙) | XC01DAD024A010010104021 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010104120 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20083577 | 60mg | Category B (乙) | XC01DAD024A010010104145 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010104166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010181656 | NHSA |
| 湖北荆江源制药股份有限公司 | 国药准字H20264264 | 40mg | Category B (乙) | XC01DAD024A010010184657 | NHSA |
| 上海世康特制药有限公司 | 国药准字H19990308 | 60mg | Category B (乙) | XC01DAD024A010010200760 | NHSA |
| 上海新亚药业闵行有限公司 | 国药准字H20010005 | 40mg | Category B (乙) | XC01DAD024A010010200795 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010643 | 40mg | Category B (乙) | XC01DAD024A010010200804 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20249430 | 40mg | Category B (乙) | XC01DAD024A010010201605 | NHSA |
| 乐声药业石家庄有限公司 | 国药准字H20020266 | 50mg | Category B (乙) | XC01DAD024A010010202680 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20066203 | 40mg | Category B (乙) | XC01DAD024A010010203094 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010204012 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010204120 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20083577 | 60mg | Category B (乙) | XC01DAD024A010010204145 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010204166 | NHSA |
| 昆明众康制药有限公司 | 国药准字H20010142 | 40毫克 | Category B (乙) | XC01DAD024A010010205588 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010281656 | NHSA |
| 湖北荆江源制药股份有限公司 | 国药准字H20264264 | 40mg | Category B (乙) | XC01DAD024A010010284657 | NHSA |
| 上海世康特制药有限公司 | 国药准字H19990308 | 60mg | Category B (乙) | XC01DAD024A010010300760 | NHSA |
| 上海新亚药业闵行有限公司 | 国药准字H20010005 | 40mg | Category B (乙) | XC01DAD024A010010300795 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010643 | 40mg | Category B (乙) | XC01DAD024A010010300804 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20249430 | 40mg | Category B (乙) | XC01DAD024A010010301605 | NHSA |
| 乐声药业石家庄有限公司 | 国药准字H20020266 | 50mg | Category B (乙) | XC01DAD024A010010302680 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20066203 | 40mg | Category B (乙) | XC01DAD024A010010303094 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010304012 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010304120 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010304166 | NHSA |
| 昆明众康制药有限公司 | 国药准字H20010142 | 40毫克 | Category B (乙) | XC01DAD024A010010305588 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010381656 | NHSA |
| 上海世康特制药有限公司 | 国药准字H19990308 | 60mg | Category B (乙) | XC01DAD024A010010400760 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010643 | 40mg | Category B (乙) | XC01DAD024A010010400804 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20249430 | 40mg | Category B (乙) | XC01DAD024A010010401605 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20066203 | 40mg | Category B (乙) | XC01DAD024A010010403094 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010404012 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010404120 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010404166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010481656 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010643 | 40mg | Category B (乙) | XC01DAD024A010010500804 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20066203 | 40mg | Category B (乙) | XC01DAD024A010010503094 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010504012 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010504120 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010504166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010581656 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H19991039 | 40mg | Category B (乙) | XC01DAD024A010010604012 | NHSA |
| 山东力诺制药有限公司 | 国药准字H19991115 | 40mg | Category B (乙) | XC01DAD024A010010604120 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010604166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010681656 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010704166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010781656 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010804166 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20249678 | 40mg | Category B (乙) | XC01DAD024A010010881656 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010010904166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010011004166 | NHSA |
| 西藏诺迪康科技发展有限公司 | 国药准字H20030418 | 60mg | Category B (乙) | XC01DAD024A010020101359 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20066717 | 40mg | Category B (乙) | XC01DAD024A010020104021 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010020104166 | NHSA |
| 昆明众康制药有限公司 | 国药准字H20010142 | 40毫克 | Category B (乙) | XC01DAD024A010020105588 | NHSA |
| 西藏诺迪康科技发展有限公司 | 国药准字H20030418 | 60mg | Category B (乙) | XC01DAD024A010020201359 | NHSA |
| 西藏诺迪康科技发展有限公司 | 国药准字H20030418 | 60mg | Category B (乙) | XC01DAD024A010020301359 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010030104166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010031104166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010031204166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010031304166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010031404166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010031504166 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20083838 | 40mg | Category B (乙) | XC01DAD024A010040104166 | 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: 5 filings and 4 distinct first applicants.
Generic 4 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东博瀚制药有限公司 | CYHS2601647 | Generic | 2026/07/09 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601170 | Generic | 2026/05/18 | Not stated by source | CDE |
| 浙江车头制药股份有限公司;九洲生物医药（台州）有限公司 | CYHS2600668 | Generic | 2026/03/17 | Not stated by source | CDE |
| 浙江车头制药股份有限公司;九洲生物医药（台州）有限公司 | CYHS2600667 | Generic | 2026/03/17 | Not stated by source | CDE |
| 上海新亚药业闵行有限公司 | CYHB2550312 | Supplement | 2025/09/03 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东博瀚制药有限公司 | CYHS2601647 | Generic | 2026/07/09 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601170 | Generic | 2026/05/18 | Not stated by source | CDE |
| 浙江车头制药股份有限公司;九洲生物医药（台州）有限公司 | CYHS2600668 | Generic | 2026/03/17 | Not stated by source | CDE |
| 浙江车头制药股份有限公司;九洲生物医药（台州）有限公司 | CYHS2600667 | Generic | 2026/03/17 | Not stated by source | CDE |
API registrations
Non-component matches: 14 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 |
|---|---|---|---|---|---|---|
| 单硝酸异山梨酯 | 瑞阳制药股份有限公司 | Y20260000493 | I | Exact ingredient | 2026/06/18 | CDE |
| 单硝酸异山梨酯 | 珠海润都制药股份有限公司 | Y20220000036 | A | Exact ingredient | 2026/03/11 | CDE |
| 单硝酸异山梨酯 | TopRidge Pharma (Ireland) Limited | Y20190009943 | A | Exact ingredient | — | CDE |
| 单硝酸异山梨酯 | TopRidge Pharma (Ireland) Limited | Y20190009942 | A | Exact ingredient | — | CDE |
| 单硝酸异山梨酯 | 山东科源制药股份有限公司 | Y20190008394 | A | Exact ingredient | 2025/01/16 | CDE |
| 单硝酸异山梨酯 | 济宁市瑞信堂大禹药业有限公司 | Y20190007048 | A | Exact ingredient | 2023/05/18 | CDE |
| 单硝酸异山梨酯 | 北京益民药业有限公司 | Y20190007012 | A | Exact ingredient | 2023/03/24 | CDE |
| 单硝酸异山梨酯 | 浙江车头制药股份有限公司 | Y20190006904 | A | Exact ingredient | 2024/08/02 | CDE |
| 单硝酸异山梨酯 | 仁和堂药业有限公司 | Y20190006202 | A | Exact ingredient | 2025/08/16 | CDE |
| 单硝酸异山梨酯 | 苏州第五制药厂有限公司 | Y20190006095 | A | Exact ingredient | — | CDE |
| 单硝酸异山梨酯 | 上海新亚药业有限公司 | Y20190004429 | A | Exact ingredient | — | CDE |
| 单硝酸异山梨酯 | 山东方明药业集团股份有限公司 | Y20190004105 | A | Exact ingredient | 2025/04/11 | CDE |
| 单硝酸异山梨酯 | 浙江海正药业股份有限公司 | Y20190003467 | A | Exact ingredient | 2024/08/27 | CDE |
| 单硝酸异山梨酯 | 山东新时代药业有限公司 | Y20190002360 | A | Exact ingredient | 2024/09/03 | CDE |
| 单硝酸异山梨酯 | 鲁南贝特制药有限公司 | Y20190002174 | A | Exact ingredient | 2025/01/21 | CDE |
| 单硝酸异山梨酯 | 上海旭东海普药业有限公司 | Y20190001494 | A | Exact ingredient | 2024/12/14 | CDE |
| 单硝酸异山梨酯 | AstraZeneca AB | Y20180001210 | I | Exact ingredient | 2018/11/13 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
- 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: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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: 2026/11/10 07:25
- 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: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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.
Free follow
Follow changes to Isosorbide Mononitrate Extended-Release Tablets
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Yearly
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy