Diclofenac Sodium Sustained Release Tablets

As of 13 November 2026, for Diclofenac Sodium Sustained Release Tablets, 10 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 14 holders.

Companies, stages and changes, with each record available on this page.

Last 90 days: Accepted: 4 applications

Current coverage may be incomplete

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Complete CDE snapshot: 2026/11/13 06:42
Matching scope: Same generic name; dosage forms and combinations kept separate
Coverage: Source dates and limits ↓

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 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
Hefei He Yuan Pharma Co., Ltd. romanized	Hefei He Yuan Pharma Co., Ltd. romanized	国药准字H20265435	2026/07/28	100mg	Generic approved under the new chemical-drug registration classification	CDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.	Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20264648	2026/06/03	100mg	Generic approved under the new chemical-drug registration classification	CDE
Liaoning Fu Yuan Pharma Co., Ltd. romanized	Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	2026/06/02	0.1g	Drug that passed quality-and-efficacy consistency evaluation	CDE
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	国药准字H20264430	2026/05/19	100mg	Generic approved under the new chemical-drug registration classification	CDE
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	国药准字H20264471	2026/05/19	75mg	Generic approved under the new chemical-drug registration classification	CDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	2026/03/03	100mg	Generic approved under the new chemical-drug registration classification	CDE
Zhejiang Di Er Pharma Co., Ltd. romanized	Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	2025/10/31	0.1g	Drug that passed quality-and-efficacy consistency evaluation	CDE
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255690	2025/10/14	75mg	Generic approved under the new chemical-drug registration classification	CDE
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255691	2025/10/14	100mg	Generic approved under the new chemical-drug registration classification	CDE
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254097	2025/05/13	100mg	Generic approved under the new chemical-drug registration classification	CDE
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254096	2025/05/13	75mg	Generic approved under the new chemical-drug registration classification	CDE
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	2024/08/27	75mg	Generic approved under the new chemical-drug registration classification	CDE
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	2023/12/18	0.1g	Drug that passed quality-and-efficacy consistency evaluation	CDE
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	国药准字H20010604	2023/09/15	0.1g	Drug that passed quality-and-efficacy consistency evaluation	CDE
Zhejiang Pu Li Pharma Co., Ltd. romanized	Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	2023/06/27	100mg	Generic approved under the new chemical-drug registration classification	CDE
Zhejiang Pu Li Pharma Co., Ltd. romanized	Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	2023/06/27	75mg	Generic approved under the new chemical-drug registration classification	CDE
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	国药准字H20213301	2021/04/27	100mg	Generic approved under the new chemical-drug registration classification	CDE
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	国药准字H20213300	2021/04/27	75mg	Generic approved under the new chemical-drug registration classification	CDE
Name not romanized	Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	2020/01/07	0.1g	Drug that passed quality-and-efficacy consistency evaluation	CDE
Hefei He Yuan Pharma Co., Ltd. romanized	Hefei He Yuan Pharma Co., Ltd. romanized	国药准字H20265436	2026/07/28	75mg	Generic approved under the new chemical-drug registration classification	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
Zhong Mei Tianjin Shi Ke Pharmaceutical Co., Ltd. romanized	国药准字H10980297	75mg	Category A	XM01ABS120A010010100100	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010100465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010100555	NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	国药准字H20264430	100mg	Category A	XM01ABS120A010010100601	NHSA
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	国药准字H20010604	0.1g	Category A	XM01ABS120A010010100818	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254096	75mg	Category A	XM01ABS120A010010101190	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010101206	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20264648	100mg	Category A	XM01ABS120A010010101503	NHSA
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	国药准字H20213300	75mg	Category A	XM01ABS120A010010101605	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010102160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010102251	NHSA
De Zhou De Yao Pharmaceutical Co., Ltd. romanized	国药准字H10970008	0.1g	Category A	XM01ABS120A010010103942	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010104623	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255690	75mg	Category A	XM01ABS120A010010104658	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010104929	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010010109531	NHSA
Hefei He Yuan Pharma Co., Ltd. romanized	国药准字H20265436	75mg	Category A	XM01ABS120A010010109541	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010182922	NHSA
Zhong Mei Tianjin Shi Ke Pharmaceutical Co., Ltd. romanized	国药准字H10980297	75mg	Category A	XM01ABS120A010010200100	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010200465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010200555	NHSA
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	国药准字H20010604	0.1g	Category A	XM01ABS120A010010200818	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254096	75mg	Category A	XM01ABS120A010010201190	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010201206	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20264648	100mg	Category A	XM01ABS120A010010201503	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010202160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010202251	NHSA
De Zhou De Yao Pharmaceutical Co., Ltd. romanized	国药准字H10970008	0.1g	Category A	XM01ABS120A010010203942	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010204623	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255690	75mg	Category A	XM01ABS120A010010204658	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010204929	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010010209531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010282922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010300465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010300555	NHSA
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	国药准字H20010604	0.1g	Category A	XM01ABS120A010010300818	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254096	75mg	Category A	XM01ABS120A010010301190	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010301206	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20264648	100mg	Category A	XM01ABS120A010010301503	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010302160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010302251	NHSA
De Zhou De Yao Pharmaceutical Co., Ltd. romanized	国药准字H10970008	0.1g	Category A	XM01ABS120A010010303942	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010304623	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255690	75mg	Category A	XM01ABS120A010010304658	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010304929	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010382922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010400465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010400555	NHSA
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized	国药准字H20010604	0.1g	Category A	XM01ABS120A010010400818	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010401206	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20264648	100mg	Category A	XM01ABS120A010010401503	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010402160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010402251	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010404623	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255690	75mg	Category A	XM01ABS120A010010404658	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010404929	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010482922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010500465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010500555	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010501206	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010502160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010502251	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010504623	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010504929	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010582922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010600465	NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized	国药准字H10970209	0.1g	Category A	XM01ABS120A010010600555	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010601206	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010602160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010602251	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010604623	NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD	国药准字H20067776	0.1g	Category A	XM01ABS120A010010604929	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010682922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010700465	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010701206	NHSA
Sichuan Hua Xin Pharmaceutical Co., Ltd. romanized	国药准字H19991402	0.1g	Category A	XM01ABS120A010010702160	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010702251	NHSA
Zhejiang Di Er Pharma Co., Ltd. romanized	国药准字H20083921	0.1g	Category A	XM01ABS120A010010704623	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010782922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010800465	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010801206	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010802251	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010882922	NHSA
Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized	国药准字H20244747	75mg	Category A	XM01ABS120A010010900465	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010010901206	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010010902251	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010010982922	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010011002251	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233809	75mg	Category A	XM01ABS120A010011082922	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011101206	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010011102251	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011201206	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	XM01ABS120A010011202251	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011301206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011401206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011501206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010011601206	NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	国药准字H20264471	75mg	Category A	XM01ABS120A010020100601	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254097	100mg	Category A	XM01ABS120A010020101190	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010020101206	NHSA
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized	国药准字H20213301	100mg	Category A	XM01ABS120A010020101605	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255691	100mg	Category A	XM01ABS120A010020104658	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020109531	NHSA
Hefei He Yuan Pharma Co., Ltd. romanized	国药准字H20265435	100mg	Category A	XM01ABS120A010020109541	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020182922	NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	国药准字H20264471	75mg	Category A	XM01ABS120A010020200601	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254097	100mg	Category A	XM01ABS120A010020201190	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255691	100mg	Category A	XM01ABS120A010020204658	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020209531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020282922	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254097	100mg	Category A	XM01ABS120A010020301190	NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD.	国药准字H20255691	100mg	Category A	XM01ABS120A010020304658	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020309531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020382922	NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized	国药准字H20254097	100mg	Category A	XM01ABS120A010020401190	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020409531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020482922	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020509531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020582922	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020609531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020682922	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020709531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020782922	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020809531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020882922	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010020909531	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010020982922	NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized	国药准字H20233810	100mg	Category A	XM01ABS120A010021082922	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010021701206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010021801206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010021901206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022001206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022101206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022201206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022301206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022401206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022501206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022601206	NHSA
Liaoning Fu Yuan Pharma Co., Ltd. romanized	国药准字H20194038	0.1g	Category A	XM01ABS120A010022701206	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010030109531	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010030209531	NHSA
Ya Bao Pharma Group Co., Ltd. romanized	国药准字H20103737	See source	Category A	XM01ABS120A010030309531	NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized	国药准字H20263511	100mg	Category A	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

Current under-review applications
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	CYHB2601687	Supplement	2026/09/04	Not stated by source	CDE
Jin Yao Da Ren Tang Group Co., Ltd. Xin Xin Pharmaceutical Factory romanized	CYHB2601639	Supplement	2026/08/26	Not stated by source	CDE
Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized	CYHS2602079	Generic	2026/08/20	Not stated by source	CDE
Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized	CYHS2602078	Generic	2026/08/20	Not stated by source	CDE
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD	CYHS2600541	Generic	2026/02/26	Not stated by source	CDE
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD	CYHS2600540	Generic	2026/02/26	Not stated by source	CDE
Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized	CYHS2600016	Generic	2026/01/05	Not stated by source	CDE
Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized	CYHS2600015	Generic	2026/01/05	Not stated by source	CDE
Yun Peng Pharmaceuticals Group Co., Ltd. romanized	CYHS2503698	Generic	2025/10/16	Not stated by source	CDE
Hunan Jiudian Pharmaceutical Co., Ltd	CYHS2502819	Generic	2025/08/05	Not stated by source	CDE

New generic filings in 2026

Loaded records: 6 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized	CYHS2602079	Generic	2026/08/20	Not stated by source	CDE
Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized	CYHS2602078	Generic	2026/08/20	Not stated by source	CDE
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD	CYHS2600541	Generic	2026/02/26	Not stated by source	CDE
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD	CYHS2600540	Generic	2026/02/26	Not stated by source	CDE
Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized	CYHS2600016	Generic	2026/01/05	Not stated by source	CDE
Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized	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 · No verified English name	Aarti Drugs Ltd	Y20240001007	A	Salt-normalized ingredient	2026/04/27	CDE
双氯芬酸钠 · No verified English name	Shaanxi Xi Yue Pharmaceutical (Fu Feng) Co., Ltd. romanized	Y20230000461	A	Exact ingredient	2025/12/05	CDE
双氯芬酸钠 · No verified English name	Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized	Y20220000113	A	Exact ingredient	2025/09/01	CDE
双氯芬酸钠 · No verified English name	Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)	Y20210000887	A	Exact ingredient	2026/04/29	CDE
双氯芬酸钠 · No verified English name	Shang Qiu Shi Long Xing Pharmaceutical Co., Ltd. romanized	Y20190021638	A	Exact ingredient	2025/06/06	CDE
双氯芬酸钠 · No verified English name	Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized	Y20190021545	A	Exact ingredient	2026/03/31	CDE
双氯芬酸钾 · No verified English name	Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized	Y20180001783	A	Salt-normalized ingredient	2024/03/13	CDE
双氯芬酸钾 · No verified English name	Novartis Pharma AG	Y20190009930	A	Salt-normalized ingredient	—	CDE
双氯芬酸钠 · No verified English name	Henan Sheng Lian Yi Pharmaceutical Co., Ltd. romanized	Y20190009840	A	Exact ingredient	2024/01/17	CDE
双氯芬酸钠 · No verified English name	Ningbo Si Mai Ke Pharmaceutical Co., Ltd. romanized	Y20190009675	A	Exact ingredient	2025/07/04	CDE
双氯芬酸钠 · No verified English name	Henan Dong Tai Pharmaceutical Co., Ltd. romanized	Y20190009545	A	Exact ingredient	2025/04/24	CDE
双氯芬酸钠 · No verified English name	Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized	Y20190008694	A	Exact ingredient	2025/07/23	CDE
双氯芬酸钾 · No verified English name	Liaoning Xing Hai Pharmaceutical Co., Ltd. romanized	Y20190008506	A	Salt-normalized ingredient	2025/04/15	CDE
双氯芬酸钠 · No verified English name	Topfond Pharmaceutical Co., Ltd.	Y20190007651	A	Exact ingredient	2024/05/09	CDE
双氯芬酸钠 · No verified English name	Henan Kang Da Pharmaceutical Co., Ltd. romanized	Y20190007641	A	Exact ingredient	2024/06/18	CDE
双氯芬酸钠 · No verified English name	Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized	Y20190006619	A	Exact ingredient	2026/08/17	CDE
双氯芬酸钠 · No verified English name	Jilin Jin Heng Pharmaceutical Co., Ltd. romanized	Y20190006275	A	Exact ingredient	2026/05/09	CDE
双氯芬酸钠 · No verified English name	Hao Yi Sheng Pharma Group Co., Ltd. romanized	Y20190005988	A	Exact ingredient	—	CDE
双氯芬酸钠 · No verified English name	Qingdao Shou He Jin Hai Pharmaceutical Co., Ltd. romanized	Y20190005407	A	Exact ingredient	2024/01/12	CDE
双氯芬酸钠 · No verified English name	Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Ying Chun Branch romanized	Y20190005252	A	Exact ingredient	2024/03/07	CDE
双氯芬酸钾 · No verified English name	Xi Nan Pharma Co., Ltd. romanized	Y20190005229	A	Salt-normalized ingredient	2025/02/07	CDE
双氯芬酸钾 · No verified English name	Suzhou Di Wu Pharmaceutical Factory Co., Ltd. romanized	Y20190005077	A	Salt-normalized ingredient	—	CDE
双氯芬酸钠 · No verified English name	Suzhou Di Wu Pharmaceutical Factory Co., Ltd. romanized	Y20190005067	A	Exact ingredient	—	CDE
双氯芬酸钾 · No verified English name	Suzhou Hong Sen Pharma Co., Ltd. romanized	Y20190004729	A	Salt-normalized ingredient	2025/06/28	CDE
双氯芬酸钠 · No verified English name	Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized	Y20190004481	A	Exact ingredient	2024/08/09	CDE
双氯芬酸钠 · No verified English name	Tie Ling Tian De Pharmaceutical Co., Ltd. romanized	Y20190004180	A	Exact ingredient	2026/01/14	CDE
双氯芬酸钠 · No verified English name	Hua Run Shuang He Pharma Co., Ltd. romanized	Y20190004125	A	Exact ingredient	—	CDE
双氯芬酸钾 · No verified English name	Chongqing Xi Nan He Cheng Pharmaceutical Co., Ltd. romanized	Y20190003309	A	Salt-normalized ingredient	—	CDE
双氯芬酸钠 · No verified English name	Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized	Y20190003149	A	Exact ingredient	2025/06/12	CDE
双氯芬酸钾 · No verified English name	Henan Dong Tai Pharmaceutical Co., Ltd. romanized	Y20190002892	A	Salt-normalized ingredient	2025/04/11	CDE
双氯芬酸钠 · No verified English name	Tai Shan Shi Xin Ning Pharmaceutical Co., Ltd. romanized	Y20190002795	A	Exact ingredient	2026/02/28	CDE
双氯芬酸钠 · No verified English name	Jilin Sheng Si He Pharma Technology Co., Ltd. romanized	Y20190002756	A	Exact ingredient	2025/01/04	CDE
双氯芬酸钠 · No verified English name	Da Lian Ming Sen Pharmaceutical Co., Ltd. romanized	Y20190002722	A	Exact ingredient	2026/07/16	CDE
双氯芬酸钾 · No verified English name	Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized	Y20190002713	A	Salt-normalized ingredient	2025/04/24	CDE
双氯芬酸钾 · No verified English name	Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized	Y20190002568	A	Salt-normalized ingredient	—	CDE
双氯芬酸钠 · No verified English name	Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized	Y20190002133	A	Exact ingredient	2025/09/24	CDE
双氯芬酸钾 · No verified English name	Shandong Ke Yuan Pharmaceutical Co., Ltd. romanized	Y20190001590	A	Salt-normalized ingredient	2025/01/04	CDE
双氯芬酸钠 · No verified English name	Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized	Y20190001283	A	Exact ingredient	2024/08/16	CDE
双氯芬酸钠 · No verified English name	Aarti Drugs Limited	Y20180001563	A	Exact ingredient	2026/06/12	CDE
双氯芬酸钠 · No verified English name	Henan Sheng Lian Yi Pharmaceutical Co., Ltd. romanized	Y20180001546	I	Exact ingredient	2019/02/03	CDE
双氯芬酸钠 · No verified English name	Yong Ri Chemical Gong Ye Co., Ltd. Tai Zhong You Shi Factory romanized	Y20180000602	I	Exact ingredient	2018/10/15	CDE
双氯芬酸钠 · No verified English name	Henan Dong Tai Pharmaceutical Co., Ltd. romanized	Y20170002246	I	Exact ingredient	2019/05/17	CDE
双氯芬酸钾 · No verified English name	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: 2026/11/13 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.

2026/09/04Accepted

Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
CYHB2601687

Fact date: 2026/09/04 · Site observation date: 2026/10/22
View source ↗
2026/08/26Accepted

Jin Yao Da Ren Tang Group Co., Ltd. Xin Xin Pharmaceutical Factory romanized
CYHB2601639

Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗
2026/08/20Accepted

Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized
CYHS2602079

Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗
2026/08/20Accepted

Tianjin Mei Hua Biopharmaceuticals Technology Co., Ltd. romanized
CYHS2602078

Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗

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

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.

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.

About the Chinese official sources

These pages organize dated records from Chinese official sources. English drug labels use verified official primary names; original Chinese source names remain available in CSV exports.

CDE — The Center for Drug Evaluation lists application acceptances and applications currently under review.
CDE catalogue — The chemical-drug catalogue lists approvals, marketing authorisation holders and the original inclusion categories.
NHSA — The National Healthcare Security Administration maintains medicine codes, companies and approval numbers; its database is not an application decision register.
NMPA — The National Medical Products Administration publishes delivery notices for approval documents and notifications. Loaded notices do not cover all historical approvals.
CDE API registry — The active pharmaceutical ingredient registry lists registrations and their A/I association-review status.
Drug Clinical Trial Registry — Public registration numbers, applicants, first-publication dates and original classifications/phases. States are dated site observations; revisions are not continuously tracked.

Official English name source: NMPA reference-product directory, Shaanxi MPA republication · 49-52

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