Monthly
US$200
Billed every month
Olopatadine Hydrochloride Eye Drops(盐酸奥洛他定滴眼液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications
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 holders1View records ↓
Under-review filings13View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers43View records ↓
API companies with A status16View records ↓
Chemical-drug catalogue
Loaded records: 1 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 |
|---|---|---|---|---|---|---|
| Novartis Europharm Limited | S.A.Alcon Couvreur N.V. | H20181146 | 2002/06/13 | 0.1%（5ml:5mg，以C21H23NO3计） | 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.
NHSA drug codes
Loaded records: 43 distinct approval numbers and 34 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广东南国药业有限公司 | 国药准字H20265833 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010100315 | NHSA |
| 汕头经济特区明治医药有限公司 | 国药准字H20254147 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010100483 | NHSA |
| 深圳万和制药有限公司 | 国药准字H20253371 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010100547 | NHSA |
| 沈阳兴齐眼药股份有限公司 | 国药准字H20193101 | 0.1%(5ml:5mg，以C21H23NO3计) | Category B (乙) | XS01GXA210G010010101322 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20255814 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010101438 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010101442 | NHSA |
| 苏州乐珠制药有限公司 | 国药准字H20243121 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010101652 | NHSA |
| 湖北远大天天明制药有限公司 | 国药准字H20249048 | 0.2%(0.4ml:0.8mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010101967 | NHSA |
| 武汉五景药业有限公司 | 国药准字H20264530 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010101978 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20244478 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010102087 | NHSA |
| 成都普什制药有限公司 | 国药准字H20234561 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010102298 | NHSA |
| 河北创健药业有限公司 | 国药准字H20083826 | 0.1% | Category B (乙) | XS01GXA210G010010102680 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010102733 | NHSA |
| 长春迪瑞制药有限公司 | 国药准字H20263810 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010103305 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20183099 | 0.1%(5ml:5mg,按C21H23NO3计算) | Category B (乙) | XS01GXA210G010010104021 | NHSA |
| 合肥华威药业有限公司 | 国药准字H20233973 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010104388 | NHSA |
| 国药集团三益药业(芜湖)有限公司 | 国药准字H20243943 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010104454 | NHSA |
| 浙江尖峰药业有限公司 | 国药准字H20193095 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010104655 | NHSA |
| 浙江莎普爱思药业股份有限公司 | 国药准字H20253402 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010104693 | NHSA |
| 江西马应龙美康药业有限公司 | 国药准字H20255181 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010105293 | NHSA |
| 江西科伦药业有限公司 | 国药准字H20183402 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010105319 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010105816 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20234503 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010105847 | NHSA |
| 广东宏盈科技有限公司 | 国药准字H20173398 | 0.1%(5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010107415 | NHSA |
| 参天制药(中国)有限公司 | 国药准字H20183436 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010109591 | NHSA |
| 北京汇恩兰德制药股份有限公司 | 国药准字H20203419 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010010109909 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H20265956 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010110144 | NHSA |
| 河北创健药业有限公司 | 国药准字H20234645 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010110364 | NHSA |
| Novartis Europharm Limited | 国药准字HJ20181146 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃ 计) | Category B (乙) | XS01GXA210G010010178195 | NHSA |
| Novartis pharmaceuticals Corporation | 国药准字HJ20200062 | 0.2%(2.5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010179584 | NHSA |
| 华润紫竹药业有限公司 | 国药准字H20243440 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010183035 | NHSA |
| 北京汇恩兰德制药股份有限公司 | 国药准字H20258231 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010183060 | NHSA |
| 山东威智百科药业有限公司 | 国药准字H20233505 | 0.1%(5ml:5mg,以C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010183124 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20256442 | 0.2%(2.5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010183549 | NHSA |
| 艾尔健康眼药(辽宁)有限公司 | 国药准字H20243749 | 0.1%(5ml:5mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010184070 | NHSA |
| 艾视制药有限公司 | 国药准字H20249046 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010184160 | NHSA |
| 湖北远大天天明制药有限公司 | 国药准字H20249048 | 0.2%(0.4ml:0.8mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010201967 | NHSA |
| 武汉五景药业有限公司 | 国药准字H20264530 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010201978 | NHSA |
| 成都普什制药有限公司 | 国药准字H20234561 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010202298 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010202733 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010205816 | NHSA |
| 华润紫竹药业有限公司 | 国药准字H20243440 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010283035 | NHSA |
| 湖北远大天天明制药有限公司 | 国药准字H20249048 | 0.2%(0.4ml:0.8mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010301967 | NHSA |
| 武汉五景药业有限公司 | 国药准字H20264530 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010301978 | NHSA |
| 成都普什制药有限公司 | 国药准字H20234561 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010302298 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010302733 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010305816 | NHSA |
| 华润紫竹药业有限公司 | 国药准字H20243440 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010383035 | NHSA |
| 湖北远大天天明制药有限公司 | 国药准字H20249048 | 0.2%(0.4ml:0.8mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010401967 | NHSA |
| 成都普什制药有限公司 | 国药准字H20234561 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010402298 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010402733 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010405816 | NHSA |
| 湖北远大天天明制药有限公司 | 国药准字H20249048 | 0.2%(0.4ml:0.8mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010010501967 | NHSA |
| 成都普什制药有限公司 | 国药准字H20234561 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010502298 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010502733 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010505816 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249754 | 0.1%(0.4ml:0.4mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010010602733 | NHSA |
| 沈阳兴齐眼药股份有限公司 | 国药准字H20249276 | 0.2%(2.5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010020101322 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010020101442 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020102733 | NHSA |
| 长春迪瑞制药有限公司 | 国药准字H20263809 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020103305 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20204033 | 0.1%(0.4ml:0.4mg,按C21H23NO3计算) | Category B (乙) | XS01GXA210G010020104021 | NHSA |
| 浙江尖峰药业有限公司 | 国药准字H20247155 | 0.1%(0.4ml:0.4mg,以C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020104655 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20233103 | 0.1%( 0.4ml:0.4mg, 按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020105816 | NHSA |
| 广东宏盈科技有限公司 | 国药准字H20173398 | 0.1%(5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010020107415 | NHSA |
| 华润紫竹药业有限公司 | 国药准字H20243440 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020183035 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020202733 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020302733 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020402733 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020502733 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20249755 | 0.2%(0.4ml:0.8mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010020602733 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010030101442 | NHSA |
| 石家庄格瑞药业有限公司 | 国药准字H20254150 | 0.1%(5ml:5mg,按C₂₁H₂₃NO₃计) | Category B (乙) | XS01GXA210G010030102733 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20204033 | 0.1%(0.4ml:0.4mg,按C21H23NO3计算) | Category B (乙) | XS01GXA210G010030104021 | NHSA |
| 广东宏盈科技有限公司 | 国药准字H20173398 | 0.1%(5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010030107415 | NHSA |
| 华润紫竹药业有限公司 | 国药准字H20233951 | 0.1%(0.4m1:0.4mg,按CaHzNO3计) | Category B (乙) | XS01GXA210G010030183035 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010040101442 | NHSA |
| 广东宏盈科技有限公司 | 国药准字H20173398 | 0.1%(5ml:5mg,按C21H23NO3计) | Category B (乙) | XS01GXA210G010040107415 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010050101442 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20183349 | 0.1%(5ml:5mg,以C21H23NO3计) | Category B (乙) | XS01GXA210G010060101442 | 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: 13 filings and 13 distinct first applicants.
Generic 10 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2601339 | Generic | 2026/06/08 | Not stated by source | CDE |
| 江苏福邦药业有限公司 | CYHB2502477 | Supplement | 2025/12/05 | Not stated by source | CDE |
| 南京帝昌医药科技有限公司;苏州欧康维视生物科技有限公司 | CYHS2602464 | Generic | 2026/10/09 | Not stated by source | CDE |
| 珍视明（江西）药业股份有限公司 | CYHS2602205 | Generic | 2026/09/04 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2601145 | Generic | 2026/05/14 | Not stated by source | CDE |
| 成都普什制药有限公司 | CYHB2600909 | Supplement | 2026/05/13 | Not stated by source | CDE |
| 山东博士伦福瑞达制药有限公司 | CYHS2600880 | Generic | 2026/04/17 | Not stated by source | CDE |
| 中国大冢制药有限公司 | CYHS2600474 | Generic | 2026/02/13 | Not stated by source | CDE |
| 山东辰欣佛都药业股份有限公司 | CYHS2504403 | Generic | 2025/12/25 | Not stated by source | CDE |
| Novartis Europharm Limited;Novartis Manufacturing NV | JYHB2500521 | Supplement | 2025/10/14 | Not stated by source | CDE |
| 润尔眼科药物（广州）有限公司 | CYHS2503239 | Generic | 2025/09/03 | Not stated by source | CDE |
| 四川禾亿制药有限公司 | CYHS2502362 | Generic | 2025/07/04 | Not stated by source | CDE |
| 广州维奥康药业科技有限公司;广州华圣制药有限公司 | CYHS2501637 | Generic | 2025/05/01 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2601339 | Generic | 2026/06/08 | Not stated by source | CDE |
| 南京帝昌医药科技有限公司;苏州欧康维视生物科技有限公司 | CYHS2602464 | Generic | 2026/10/09 | Not stated by source | CDE |
| 珍视明（江西）药业股份有限公司 | CYHS2602205 | Generic | 2026/09/04 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2601145 | Generic | 2026/05/14 | Not stated by source | CDE |
| 山东博士伦福瑞达制药有限公司 | CYHS2600880 | Generic | 2026/04/17 | Not stated by source | CDE |
| 中国大冢制药有限公司 | CYHS2600474 | Generic | 2026/02/13 | Not stated by source | CDE |
API registrations
Non-component matches: 16 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 |
|---|---|---|---|---|---|---|
| 盐酸奥洛他定 | Precise Biopharma Pvt Ltd | Y20240001453 | I | Exact ingredient | 2025/10/16 | CDE |
| 盐酸奥洛他定 | 石家庄格瑞药业有限公司 | Y20230000466 | A | Exact ingredient | 2025/09/29 | CDE |
| 盐酸奥洛他定 | 新乡海滨药业有限公司 | Y20220001158 | A | Exact ingredient | 2024/06/21 | CDE |
| 盐酸奥洛他定 | 江苏迪赛诺制药有限公司 | Y20200001291 | A | Exact ingredient | 2023/01/04 | CDE |
| 盐酸奥洛他定 | 四川子仁制药有限公司 | Y20200000735 | A | Exact ingredient | 2022/10/28 | CDE |
| 盐酸奥洛他定 | 河北创健药业有限公司 | Y20200000675 | A | Exact ingredient | 2024/02/21 | CDE |
| 盐酸奥洛他定 | CURIA SPAIN S.A.U. | Y20190009103 | A | Exact ingredient | 2026/10/14 | CDE |
| 盐酸奥洛他定 | CRYSTAL PHARMA S.A.U. | Y20190009102 | A | Exact ingredient | — | CDE |
| 盐酸奥洛他定 | Kyowa Hakko Kirin Co.,Ltd. | Y20190009080 | A | Exact ingredient | — | CDE |
| 盐酸奥洛他定 | 重庆西南制药二厂有限责任公司 | Y20190008886 | A | Exact ingredient | — | CDE |
| 盐酸奥洛他定 | 常州亚邦制药有限公司 | Y20190008405 | A | Exact ingredient | 2024/08/29 | CDE |
| 盐酸奥洛他定 | 武邑慈航药业有限公司 | Y20190007169 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸奥洛他定 | 齐鲁制药有限公司 | Y20190006800 | A | Exact ingredient | — | CDE |
| 盐酸奥洛他定 | 晋城海斯制药有限公司 | Y20170001002 | A | Exact ingredient | 2023/05/16 | CDE |
| 盐酸奥洛他定 | PCAS Finland Oy | Y20170000692 | A | Exact ingredient | 2024/10/29 | CDE |
| 盐酸奥洛他定 | MSN Laboratories Private Limited | Y20170000299 | A | Exact ingredient | 2024/12/31 | CDE |
| 盐酸奥洛他定 | 重庆胜凯制药有限公司 | Y20170000273 | A | Exact ingredient | 2025/04/22 | 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.
-
2026/10/20Marketing application approved
广州大光制药有限公司
CYHS2502787 · 国药准字H20266329
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 96 ↗ -
2026/10/09Accepted
南京帝昌医药科技有限公司;苏州欧康维视生物科技有限公司
CYHS2602464
Fact date: 2026/10/09 · Site observation date: 2026/10/21
View source ↗ -
2026/09/04Accepted
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.
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