Monthly
US$200
Billed every month
Diclofenac Sodium Sustained Release Tablets(双氯芬酸钠缓释片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 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 holders14View records ↓
Under-review filings10View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers24View records ↓
API companies with A status36View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 5 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 合肥合源药业有限公司 | 合肥合源药业有限公司 | 国药准字H20265435 | 2026/07/28 | 100mg | 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 |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20264648 | 2026/06/03 | 100mg | 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 |
| 辽宁福源药业有限公司 | 辽宁福源药业有限公司 | 国药准字H20194038 | 2026/06/02 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 珠海润都制药股份有限公司 | 珠海润都制药股份有限公司 | 国药准字H20264430 | 2026/05/19 | 100mg | 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 |
| 珠海润都制药股份有限公司 | 珠海润都制药股份有限公司 | 国药准字H20264471 | 2026/05/19 | 75mg | 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 |
| 四川依科制药有限公司 | 四川依科制药有限公司 | 国药准字H20263511 | 2026/03/03 | 100mg | 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 |
| 浙江迪耳药业有限公司 | 浙江迪耳药业有限公司 | 国药准字H20083921 | 2025/10/31 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江京新药业股份有限公司 | 浙江京新药业股份有限公司 | 国药准字H20255690 | 2025/10/14 | 75mg | 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 |
| 浙江京新药业股份有限公司 | 浙江京新药业股份有限公司 | 国药准字H20255691 | 2025/10/14 | 100mg | 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 |
| 锦州奥鸿药业有限责任公司 | 锦州奥鸿药业有限责任公司 | 国药准字H20254097 | 2025/05/13 | 100mg | 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 |
| 锦州奥鸿药业有限责任公司 | 锦州奥鸿药业有限责任公司 | 国药准字H20254096 | 2025/05/13 | 75mg | 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 |
| 广东香山堂制药有限公司 | 广东香山堂制药有限公司 | 国药准字H20244747 | 2024/08/27 | 75mg | 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 |
| 湖南华纳大药厂股份有限公司 | 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 2023/12/18 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 上海上药信谊药厂有限公司 | 上海上药信谊药厂有限公司 | 国药准字H20010604 | 2023/09/15 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江普利药业有限公司 | 浙江普利药业有限公司 | 国药准字H20233810 | 2023/06/27 | 100mg | 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 |
| 浙江普利药业有限公司 | 浙江普利药业有限公司 | 国药准字H20233809 | 2023/06/27 | 75mg | 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H20213301 | 2021/04/27 | 100mg | 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H20213300 | 2021/04/27 | 75mg | 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 |
| — | 国药集团致君（深圳）坪山制药有限公司 | 国药准字H10970209 | 2020/01/07 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 合肥合源药业有限公司 | 合肥合源药业有限公司 | 国药准字H20265436 | 2026/07/28 | 75mg | 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 |
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: 24 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 中美天津史克制药有限公司 | 国药准字H10980297 | 75mg | Category A (甲) | XM01ABS120A010010100100 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010100465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010100555 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20264430 | 100mg | Category A (甲) | XM01ABS120A010010100601 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H20010604 | 0.1g | Category A (甲) | XM01ABS120A010010100818 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254096 | 75mg | Category A (甲) | XM01ABS120A010010101190 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010101206 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20264648 | 100mg | Category A (甲) | XM01ABS120A010010101503 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20213300 | 75mg | Category A (甲) | XM01ABS120A010010101605 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010102160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010102251 | NHSA |
| 德州德药制药有限公司 | 国药准字H10970008 | 0.1g | Category A (甲) | XM01ABS120A010010103942 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010104623 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255690 | 75mg | Category A (甲) | XM01ABS120A010010104658 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010104929 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010010109531 | NHSA |
| 合肥合源药业有限公司 | 国药准字H20265436 | 75mg | Category A (甲) | XM01ABS120A010010109541 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010182922 | NHSA |
| 中美天津史克制药有限公司 | 国药准字H10980297 | 75mg | Category A (甲) | XM01ABS120A010010200100 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010200465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010200555 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H20010604 | 0.1g | Category A (甲) | XM01ABS120A010010200818 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254096 | 75mg | Category A (甲) | XM01ABS120A010010201190 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010201206 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20264648 | 100mg | Category A (甲) | XM01ABS120A010010201503 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010202160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010202251 | NHSA |
| 德州德药制药有限公司 | 国药准字H10970008 | 0.1g | Category A (甲) | XM01ABS120A010010203942 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010204623 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255690 | 75mg | Category A (甲) | XM01ABS120A010010204658 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010204929 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010010209531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010282922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010300465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010300555 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H20010604 | 0.1g | Category A (甲) | XM01ABS120A010010300818 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254096 | 75mg | Category A (甲) | XM01ABS120A010010301190 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010301206 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20264648 | 100mg | Category A (甲) | XM01ABS120A010010301503 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010302160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010302251 | NHSA |
| 德州德药制药有限公司 | 国药准字H10970008 | 0.1g | Category A (甲) | XM01ABS120A010010303942 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010304623 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255690 | 75mg | Category A (甲) | XM01ABS120A010010304658 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010304929 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010382922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010400465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010400555 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H20010604 | 0.1g | Category A (甲) | XM01ABS120A010010400818 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010401206 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20264648 | 100mg | Category A (甲) | XM01ABS120A010010401503 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010402160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010402251 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010404623 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255690 | 75mg | Category A (甲) | XM01ABS120A010010404658 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010404929 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010482922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010500465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010500555 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010501206 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010502160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010502251 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010504623 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010504929 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010582922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010600465 | NHSA |
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H10970209 | 0.1g | Category A (甲) | XM01ABS120A010010600555 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010601206 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010602160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010602251 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010604623 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20067776 | 0.1g | Category A (甲) | XM01ABS120A010010604929 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010682922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010700465 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010701206 | NHSA |
| 四川华新制药有限公司 | 国药准字H19991402 | 0.1g | Category A (甲) | XM01ABS120A010010702160 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010702251 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20083921 | 0.1g | Category A (甲) | XM01ABS120A010010704623 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010782922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010800465 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010801206 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010802251 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010882922 | NHSA |
| 广东香山堂制药有限公司 | 国药准字H20244747 | 75mg | Category A (甲) | XM01ABS120A010010900465 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010010901206 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010010902251 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010010982922 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010011002251 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233809 | 75mg | Category A (甲) | XM01ABS120A010011082922 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011101206 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010011102251 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011201206 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010011202251 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011301206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011401206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011501206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010011601206 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20264471 | 75mg | Category A (甲) | XM01ABS120A010020100601 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254097 | 100mg | Category A (甲) | XM01ABS120A010020101190 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010020101206 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20213301 | 100mg | Category A (甲) | XM01ABS120A010020101605 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255691 | 100mg | Category A (甲) | XM01ABS120A010020104658 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020109531 | NHSA |
| 合肥合源药业有限公司 | 国药准字H20265435 | 100mg | Category A (甲) | XM01ABS120A010020109541 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020182922 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20264471 | 75mg | Category A (甲) | XM01ABS120A010020200601 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254097 | 100mg | Category A (甲) | XM01ABS120A010020201190 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255691 | 100mg | Category A (甲) | XM01ABS120A010020204658 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020209531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020282922 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254097 | 100mg | Category A (甲) | XM01ABS120A010020301190 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20255691 | 100mg | Category A (甲) | XM01ABS120A010020304658 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020309531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020382922 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20254097 | 100mg | Category A (甲) | XM01ABS120A010020401190 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020409531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020482922 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020509531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020582922 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020609531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020682922 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020709531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020782922 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020809531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020882922 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010020909531 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010020982922 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20233810 | 100mg | Category A (甲) | XM01ABS120A010021082922 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010021701206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010021801206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010021901206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022001206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022101206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022201206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022301206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022401206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022501206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022601206 | NHSA |
| 辽宁福源药业有限公司 | 国药准字H20194038 | 0.1g | Category A (甲) | XM01ABS120A010022701206 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010030109531 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010030209531 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20103737 | 0.1g(以C14H10Cl2NNaO2计) | Category A (甲) | XM01ABS120A010030309531 | NHSA |
| 四川依科制药有限公司 | 国药准字H20263511 | 100mg | Category A (甲) | XM01ABS120A010011302251 | 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: 10 filings and 7 distinct first applicants.
Supplement 2 · Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 珠海润都制药股份有限公司 | CYHB2601687 | Supplement | 2026/09/04 | Not stated by source | CDE |
| 津药达仁堂集团股份有限公司新新制药厂 | CYHB2601639 | Supplement | 2026/08/26 | Not stated by source | CDE |
| 天津梅花生物医药科技有限公司 | CYHS2602079 | Generic | 2026/08/20 | Not stated by source | CDE |
| 天津梅花生物医药科技有限公司 | CYHS2602078 | Generic | 2026/08/20 | Not stated by source | CDE |
| 湖南状元制药有限公司;湖南华纳大药厂股份有限公司 | CYHS2600541 | Generic | 2026/02/26 | Not stated by source | CDE |
| 湖南状元制药有限公司;湖南华纳大药厂股份有限公司 | CYHS2600540 | Generic | 2026/02/26 | Not stated by source | CDE |
| 国源国药（广东）制药集团有限公司 | CYHS2600016 | Generic | 2026/01/05 | Not stated by source | CDE |
| 国源国药（广东）制药集团有限公司 | CYHS2600015 | Generic | 2026/01/05 | Not stated by source | CDE |
| 云鹏医药集团有限公司 | CYHS2503698 | Generic | 2025/10/16 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2502819 | Generic | 2025/08/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 天津梅花生物医药科技有限公司 | CYHS2602079 | Generic | 2026/08/20 | Not stated by source | CDE |
| 天津梅花生物医药科技有限公司 | CYHS2602078 | Generic | 2026/08/20 | Not stated by source | CDE |
| 湖南状元制药有限公司;湖南华纳大药厂股份有限公司 | CYHS2600541 | Generic | 2026/02/26 | Not stated by source | CDE |
| 湖南状元制药有限公司;湖南华纳大药厂股份有限公司 | CYHS2600540 | Generic | 2026/02/26 | Not stated by source | CDE |
| 国源国药（广东）制药集团有限公司 | CYHS2600016 | Generic | 2026/01/05 | Not stated by source | CDE |
| 国源国药（广东）制药集团有限公司 | CYHS2600015 | Generic | 2026/01/05 | Not stated by source | CDE |
API registrations
Non-component matches: 36 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 双氯芬酸钾 | Aarti Drugs Ltd | Y20240001007 | A | Salt-normalized ingredient | 2026/04/27 | CDE |
| 双氯芬酸钠 | 陕西西岳制药（扶风）有限公司 | Y20230000461 | A | Exact ingredient | 2025/12/05 | CDE |
| 双氯芬酸钠 | 湖南华纳大药厂手性药物有限公司 | Y20220000113 | A | Exact ingredient | 2025/09/01 | CDE |
| 双氯芬酸钠 | Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) | Y20210000887 | A | Exact ingredient | 2026/04/29 | CDE |
| 双氯芬酸钠 | 商丘市龙兴制药有限公司 | Y20190021638 | A | Exact ingredient | 2025/06/06 | CDE |
| 双氯芬酸钠 | 珠海润都制药股份有限公司 | Y20190021545 | A | Exact ingredient | 2026/03/31 | CDE |
| 双氯芬酸钾 | 上海锦帝九州药业（安阳）有限公司 | Y20180001783 | A | Salt-normalized ingredient | 2024/03/13 | CDE |
| 双氯芬酸钾 | Novartis Pharma AG | Y20190009930 | A | Salt-normalized ingredient | — | CDE |
| 双氯芬酸钠 | 河南省联谊制药有限公司 | Y20190009840 | A | Exact ingredient | 2024/01/17 | CDE |
| 双氯芬酸钠 | 宁波斯迈克制药有限公司 | Y20190009675 | A | Exact ingredient | 2025/07/04 | CDE |
| 双氯芬酸钠 | 河南东泰制药有限公司 | Y20190009545 | A | Exact ingredient | 2025/04/24 | CDE |
| 双氯芬酸钠 | 陕西西岳制药有限公司 | Y20190008694 | A | Exact ingredient | 2025/07/23 | CDE |
| 双氯芬酸钾 | 辽宁兴海制药有限公司 | Y20190008506 | A | Salt-normalized ingredient | 2025/04/15 | CDE |
| 双氯芬酸钠 | 天方药业有限公司 | Y20190007651 | A | Exact ingredient | 2024/05/09 | CDE |
| 双氯芬酸钠 | 河南康达制药有限公司 | Y20190007641 | A | Exact ingredient | 2024/06/18 | CDE |
| 双氯芬酸钠 | 上海锦帝九州药业（安阳）有限公司 | Y20190006619 | A | Exact ingredient | 2026/08/17 | CDE |
| 双氯芬酸钠 | 吉林金恒制药股份有限公司 | Y20190006275 | A | Exact ingredient | 2026/05/09 | CDE |
| 双氯芬酸钠 | 好医生药业集团有限公司 | Y20190005988 | A | Exact ingredient | — | CDE |
| 双氯芬酸钠 | 青岛首和金海制药有限公司 | Y20190005407 | A | Exact ingredient | 2024/01/12 | CDE |
| 双氯芬酸钠 | 黑龙江乌苏里江制药有限公司迎春分公司 | Y20190005252 | A | Exact ingredient | 2024/03/07 | CDE |
| 双氯芬酸钾 | 西南药业股份有限公司 | Y20190005229 | A | Salt-normalized ingredient | 2025/02/07 | CDE |
| 双氯芬酸钾 | 苏州第五制药厂有限公司 | Y20190005077 | A | Salt-normalized ingredient | — | CDE |
| 双氯芬酸钠 | 苏州第五制药厂有限公司 | Y20190005067 | A | Exact ingredient | — | CDE |
| 双氯芬酸钾 | 苏州弘森药业股份有限公司 | Y20190004729 | A | Salt-normalized ingredient | 2025/06/28 | CDE |
| 双氯芬酸钠 | 广州白云山明兴制药有限公司 | Y20190004481 | A | Exact ingredient | 2024/08/09 | CDE |
| 双氯芬酸钠 | 铁岭天德制药有限公司 | Y20190004180 | A | Exact ingredient | 2026/01/14 | CDE |
| 双氯芬酸钠 | 华润双鹤药业股份有限公司 | Y20190004125 | A | Exact ingredient | — | CDE |
| 双氯芬酸钾 | 重庆西南合成制药有限公司 | Y20190003309 | A | Salt-normalized ingredient | — | CDE |
| 双氯芬酸钠 | 武汉武药制药有限公司 | Y20190003149 | A | Exact ingredient | 2025/06/12 | CDE |
| 双氯芬酸钾 | 河南东泰制药有限公司 | Y20190002892 | A | Salt-normalized ingredient | 2025/04/11 | CDE |
| 双氯芬酸钠 | 台山市新宁制药有限公司 | Y20190002795 | A | Exact ingredient | 2026/02/28 | CDE |
| 双氯芬酸钠 | 吉林省四合药业科技有限公司 | Y20190002756 | A | Exact ingredient | 2025/01/04 | CDE |
| 双氯芬酸钠 | 大连名森制药有限公司 | Y20190002722 | A | Exact ingredient | 2026/07/16 | CDE |
| 双氯芬酸钾 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20190002713 | A | Salt-normalized ingredient | 2025/04/24 | CDE |
| 双氯芬酸钾 | 浙江金华康恩贝生物制药有限公司 | Y20190002568 | A | Salt-normalized ingredient | — | CDE |
| 双氯芬酸钠 | 辽源市百康药业有限责任公司 | Y20190002133 | A | Exact ingredient | 2025/09/24 | CDE |
| 双氯芬酸钾 | 山东科源制药股份有限公司 | Y20190001590 | A | Salt-normalized ingredient | 2025/01/04 | CDE |
| 双氯芬酸钠 | 浙江三生蔓迪药业有限公司 | Y20190001283 | A | Exact ingredient | 2024/08/16 | CDE |
| 双氯芬酸钠 | Aarti Drugs Limited | Y20180001563 | A | Exact ingredient | 2026/06/12 | CDE |
| 双氯芬酸钠 | 河南省联谊制药有限公司 | Y20180001546 | I | Exact ingredient | 2019/02/03 | CDE |
| 双氯芬酸钠 | 永日化学工业股份有限公司台中幼狮厂 | Y20180000602 | I | Exact ingredient | 2018/10/15 | CDE |
| 双氯芬酸钠 | 河南东泰制药有限公司 | Y20170002246 | I | Exact ingredient | 2019/05/17 | CDE |
| 双氯芬酸钾 | Novartis Pharma AG | Y20170001978 | A | Salt-normalized ingredient | — | 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.
-
2026/09/04Accepted
-
2026/08/26Accepted
津药达仁堂集团股份有限公司新新制药厂
CYHB2601639
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗ -
2026/08/20Accepted
-
2026/08/20Accepted
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 Diclofenac Sodium Sustained 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