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Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 applicationsNo longer listed under review: 1 application
Current coverage may be incomplete
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.
Loaded records: 2 holders; 0 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 |
|---|---|---|---|---|---|---|
| Allergan Inc. | Allergan Sales, LLC | H20160425 | 2009/08/19 | 0.15% | Imported originator drug (进口原研药品) | CDE |
| Allergan Inc. | Allergan Sales, LLC | H20160426 | 2009/08/19 | 0.15% | Imported originator drug (进口原研药品) | CDE |
| Allergan Pharmaceuticals Ireland | Allergan Pharmaceuticals Ireland | H20160681 | 2003/06/02 | 5ml:10mg | Imported originator drug (进口原研药品) | 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.
Loaded records: 18 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广东众生药业股份有限公司 | 国药准字H20253121 | 0.2%(5ml∶10mg) | Category B (乙) | XS01EAX174G010010100371 | NHSA |
| 无锡济煜山禾药业股份有限公司 | 国药准字H20080439 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010101565 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20253730 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010102733 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20080076 | 5ml :10mg | Category B (乙) | XS01EAX174G010010104010 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20213279 | 0.15%(0.3ml:0.45mg) | Category B (乙) | XS01EAX174G010010104021 | NHSA |
| 北京汇恩兰德制药股份有限公司 | 国药准字H20163241 | 5ml:10mg | Category B (乙) | XS01EAX174G010010109909 | NHSA |
| Sandoz Inc. | H20150504 | 5ml:10mg | Category B (乙) | XS01EAX174G010010178196 | NHSA |
| AbbVie Inc. | 国药准字HJ20160426 | 0.15%(5ml:7.5mg) | Category B (乙) | XS01EAX174G010010178204 | NHSA |
| AbbVie Limited | 国药准字HJ20160681 | 5ml:10mg | Category B (乙) | XS01EAX174G010010178976 | NHSA |
| 南京海纳制药有限公司 | 国药准字H20255513 | 0.15%(0.3ml:0.45mg) | Category B (乙) | XS01EAX174G010010180537 | NHSA |
| 鲁南制药集团股份有限公司 | 国药准字H20264756 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010181656 | NHSA |
| 山东威智百科药业有限公司 | 国药准字H20243347 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010183124 | NHSA |
| 汕头经济特区明治医药有限公司 | 国药准字H20253272 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010183539 | NHSA |
| 苏州欧康维视生物科技有限公司 | 国药准字H20249123 | 0.2%(5ml:10mg,按C₁₁H₁₀BrN₅·C₄H₆O₆计) | Category B (乙) | XS01EAX174G010010183562 | NHSA |
| 北京诺思兰德生物技术股份有限公司 | 国药准字H20243152 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010183698 | NHSA |
| 艾尔健康眼药(辽宁)有限公司 | 国药准字H20243748 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010184070 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254308 | 0.2%(5ml:10mg) | Category B (乙) | XS01EAX174G010010184221 | NHSA |
| 四川智强医药科技开发有限公司 | 国药准字H20249428 | 0.15%(0.3ml:0.45mg) | Category B (乙) | XS01EAX174G010010184458 | 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.
Loaded records: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏福邦药业有限公司 | CYHS2602311 | Generic | 2026/09/17 | Not stated by source | CDE |
| 复星医药(徐州)有限公司 | CYHS2600159 | Generic | 2026/01/13 | Not stated by source | CDE |
| 江苏天平药业有限公司 | CYHS2602385 | Generic | 2026/09/22 | Not stated by source | CDE |
| 大邦(湖南)生物制药有限公司 | CYHL2600102 | Generic | 2026/09/22 | Not stated by source | CDE |
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏福邦药业有限公司 | CYHS2602311 | Generic | 2026/09/17 | Not stated by source | CDE |
| 复星医药(徐州)有限公司 | CYHS2600159 | Generic | 2026/01/13 | Not stated by source | CDE |
| 江苏天平药业有限公司 | CYHS2602385 | Generic | 2026/09/22 | Not stated by source | CDE |
| 大邦(湖南)生物制药有限公司 | CYHL2600102 | Generic | 2026/09/22 | Not stated by source | CDE |
| 北京汇恩兰德制药股份有限公司 | CYHL2600009 | Generic | 2026/01/13 | Not stated by source | CDE |
| 北京汇恩兰德制药股份有限公司 | CYHL2600008 | Generic | 2026/01/13 | Not stated by source | CDE |
Non-component matches: 7 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 酒石酸溴莫尼定 | C-SQUARED PHARMA LIMITED | Y20240000181 | A | Exact ingredient | 2026/02/25 | CDE |
| 酒石酸溴莫尼定 | 石家庄格瑞药业有限公司 | Y20230001184 | A | Exact ingredient | 2026/06/02 | CDE |
| 酒石酸溴莫尼定 | CZECH-GEN, a.s. | Y20210000747 | A | Exact ingredient | 2026/10/16 | CDE |
| 酒石酸溴莫尼定 | 常州亚邦制药有限公司 | Y20190007214 | A | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 | 鲁南贝特制药有限公司 | Y20190007183 | A | Exact ingredient | 2025/12/04 | CDE |
| 酒石酸溴莫尼定 | 南京恒生制药有限公司 | Y20190007132 | A | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 | 成都新越医药有限公司 | Y20170001125 | I | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 | Indoco Remedies Ltd. (Kilo Lab) | Y20170000909 | A | Exact ingredient | 2026/04/02 | 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.
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.
CYHS2501496 · 国药准字H20266463
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 54 ↗CYHS2502464
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2025/07/11
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗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.
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.
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.
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.
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