Monthly
US$200
Billed every month
Vortioxetine Hydrobromide Tablets(氢溴酸伏硫西汀片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 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 holders27View records ↓
Under-review filings8View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers35View records ↓
API companies with A status26View records ↓
Chemical-drug catalogue
Loaded records: 27 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 26 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 |
|---|---|---|---|---|---|---|
| 华润双鹤湘中药业（湖南）有限公司 | 华润双鹤湘中药业（湖南）有限公司 | 国药准字H20264747 | 2026/06/10 | 5mg（按C18H22N2S计） | 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 |
| 吉林四环制药有限公司 | 吉林四环制药有限公司 | 国药准字H20264624 | 2026/06/03 | 10mg（按C18H22N2S计） | 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 |
| 九洲生物医药（台州）有限公司 | 九洲生物医药（台州）有限公司 | 国药准字H20263532 | 2026/03/10 | 10mg（按C18H22N2S计） | 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 |
| 九洲生物医药（台州）有限公司 | 九洲生物医药（台州）有限公司 | 国药准字H20263533 | 2026/03/10 | 5mg（按C18H22N2S计） | 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 |
| 山西远扬医药科技有限公司 | 山东裕欣药业有限公司 | 国药准字H20256346 | 2025/12/22 | 10mg（按C18H22N2S计） | 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 |
| 海南倍康医药科技有限公司 | 成都倍特药业股份有限公司 | 国药准字H20256261 | 2025/12/16 | 10mg（按C18H22N2S计） | 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 |
| 合肥创新医药技术有限公司 | 安徽金太阳生化药业有限公司 | 国药准字H20255943 | 2025/11/12 | 20mg（按C18H22N2S计） | 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 |
| 合肥创新医药技术有限公司 | 安徽金太阳生化药业有限公司 | 国药准字H20255942 | 2025/11/12 | 10mg | 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 |
| 重庆药友制药有限责任公司 | 重庆药友制药有限责任公司 | 国药准字H20255601 | 2025/09/30 | 10mg（以C18H22N2S计） | 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 |
| 普济生物科技（台州）有限公司 | 乐普制药科技有限公司 | 国药准字H20255195 | 2025/08/26 | 10mg（按C18H22N2S计） | 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 |
| 普济生物科技（台州）有限公司 | 乐普制药科技有限公司 | 国药准字H20255194 | 2025/08/26 | 5mg（按C18H22N2S计） | 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 |
| 湖南省湘中制药有限公司 | 湖南省湘中制药有限公司 | 国药准字H20254349 | 2025/05/27 | 10mg（按C18H22N2S计） | 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 |
| 石家庄龙泽制药股份有限公司 | 石家庄龙泽制药股份有限公司 | 国药准字H20253149 | 2025/01/14 | 10mg（以C18H22N2S计） | 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 |
| 中山万汉制药有限公司 | 中山万汉制药有限公司 | 国药准字H20253190 | 2025/01/14 | 5mg (按C18H22N2S计) | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20253161 | 2025/01/14 | 5mg（以C18H22N2S计） | 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 |
| 江苏恩华药业股份有限公司 | 江苏恩华药业股份有限公司 | 国药准字H20253153 | 2025/01/14 | 10mg（以C18H22N2S计） | 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 |
| 中山万汉制药有限公司 | 中山万汉制药有限公司 | 国药准字H20253191 | 2025/01/14 | 10mg (按C18H22N2S计) | 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 |
| 杭州和康药业有限公司 | 杭州和康药业有限公司 | 国药准字H20249594 | 2024/12/01 | 10mg(以C18H22N2S计） | 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 |
| 北大医药股份有限公司 | 北大医药股份有限公司 | 国药准字H20249356 | 2024/11/15 | 5mg（按C<sub>18</sub>H<sub>22</sub>N<sub>2</sub>S计） | 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 |
| 北大医药股份有限公司 | 北大医药股份有限公司 | 国药准字H20249358 | 2024/11/15 | 20mg（以C<sub>18</sub>H<sub>22</sub>N<sub>2</sub>S计） | 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 |
| 北大医药股份有限公司 | 北大医药股份有限公司 | 国药准字H20249357 | 2024/11/15 | 10mg（按C<sub>18</sub>H<sub>22</sub>N<sub>2</sub>S计） | 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 |
| 福建省闽东力捷迅药业股份有限公司 | 福建省闽东力捷迅药业股份有限公司 | 国药准字H20244342 | 2024/06/28 | 10mg（按 C<sub>18</sub>H<sub>22</sub>N<sub>2</sub>S 计 ） | 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 |
| 山东京卫制药有限公司 | 山东京卫制药有限公司 | 国药准字H20243891 | 2024/06/04 | 10mg（以C18H22N2S计） | 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 |
| 辰欣药业股份有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20243147 | 2024/02/06 | 10mg（以C18H22N2S计） | 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 |
| 辰欣药业股份有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20243148 | 2024/02/06 | 5mg（以C18H22N2S计） | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20243027 | 2024/01/09 | 10mg（以C18H22N2S计） | 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 |
| 河北龙海药业有限公司 | 河北龙海药业有限公司 | 国药准字H20233417 | 2023/04/04 | 10mg（以C18H22N2S计） | 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 |
| 扬子江药业集团有限公司 | 扬子江药业集团有限公司 | 国药准字H20233155 | 2023/02/14 | 10mg（按C18H22N2S计） | 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 |
| 南京方生和医药科技有限公司 | 以岭万洲国际制药有限公司 | 国药准字H20223341 | 2022/05/25 | 10mg（以C18H22N2S计） | 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 |
| 江苏豪森药业集团有限公司 | 江苏豪森药业集团有限公司 | 国药准字H20223282 | 2022/05/10 | 20mg（按C18H22N2S计） | 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 |
| 江苏豪森药业集团有限公司 | 江苏豪森药业集团有限公司 | 国药准字H20223303 | 2022/05/10 | 10mg（按C18H22N2S计） | 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 |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H20223237 | 2022/04/19 | 10mg（以伏硫西汀计） | 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 |
| 成都康弘药业集团股份有限公司 | 成都康弘药业集团股份有限公司 | 国药准字H20213844 | 2021/11/03 | 10mg(以C18H22N2S计) | 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 |
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20213823 | 2021/10/26 | 10mg（以C18H22N2S计） | 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 |
| 正大天晴药业集团股份有限公司 | 正大天晴药业集团股份有限公司 | 国药准字H20213597 | 2021/07/20 | 5mg（按C18H22N2S计） | 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 |
| 正大天晴药业集团股份有限公司 | 正大天晴药业集团股份有限公司 | 国药准字H20213598 | 2021/07/20 | 10mg（按C18H22N2S计） | 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 |
| H.Lundbeck A/S | H.Lundbeck A/S | H20170381;H20170382 | 2017/11/21 | 5mg(以C18H22N2S计） | Imported originator drug (进口原研药品) | CDE |
| H.Lundbeck A/S | H.Lundbeck A/S | H20170383;H20170384 | 2017/11/21 | 10mg(以C18H22N2S计） | Imported originator drug (进口原研药品) | CDE |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H20223436 | 2022/06/28 | 5mg（以伏硫西汀计） | 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: 35 distinct approval numbers and 23 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏恩华药业股份有限公司 | 国药准字H20253153 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010101435 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223303 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010101444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213597 | 5mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001010101523 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20233155 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010101749 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20213823 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010102013 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20213844 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010102016 | NHSA |
| 石家庄四药有限公司 | 国药准字H20243027 | 10mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001010102763 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233417 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010102766 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223436 | 5mg(以伏硫西汀计) | Not stated by source | XN06AXF704A001010102770 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20264624 | 10mg(按 C₁₈H₂₂N₂S 计) | Not stated by source | XN06AXF704A001010103492 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20243891 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010104111 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243147 | 10mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001010104127 | NHSA |
| 福建省闽东力捷迅药业股份有限公司 | 国药准字H20244342 | 10mg(按C₁₈H₂₂N₂S 计 ) | Not stated by source | XN06AXF704A001010104799 | NHSA |
| 华润双鹤湘中药业(湖南)有限公司 | 国药准字H20254349 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010104971 | NHSA |
| 北大医药股份有限公司 | 国药准字H20249356 | 5mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010109586 | NHSA |
| 中山万汉制药有限公司 | 国药准字H20253190 | 5mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010109920 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20170383 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010178996 | NHSA |
| 石家庄龙泽制药股份有限公司 | 国药准字H20253149 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010179261 | NHSA |
| 南京方生和医药科技有限公司 | 国药准字H20223341 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010181048 | NHSA |
| 杭州和康药业有限公司 | 国药准字H20249594 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010181760 | NHSA |
| 山西远扬医药科技有限公司 | 国药准字H20256346 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010183363 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255194 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010184207 | NHSA |
| 海南倍康医药科技有限公司 | 国药准字H20256261 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010185151 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223303 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010201444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213597 | 5mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001010201523 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233417 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010202766 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20264624 | 10mg(按 C₁₈H₂₂N₂S 计) | Not stated by source | XN06AXF704A001010203492 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20243891 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010204111 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20170383 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010278996 | NHSA |
| 杭州和康药业有限公司 | 国药准字H20249594 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010281760 | NHSA |
| 山西远扬医药科技有限公司 | 国药准字H20256346 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010283363 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255194 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010284207 | NHSA |
| 海南倍康医药科技有限公司 | 国药准字H20256261 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010285151 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223303 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010301444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213597 | 5mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001010301523 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233417 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010302766 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20264624 | 10mg(按 C₁₈H₂₂N₂S 计) | Not stated by source | XN06AXF704A001010303492 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20243891 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010304111 | NHSA |
| H.Lundbeck A/S | H20170384 | 10mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001010378996 | NHSA |
| 杭州和康药业有限公司 | 国药准字H20249594 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010381760 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223303 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010401444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213597 | 5mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001010401523 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233417 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001010402766 | NHSA |
| H.Lundbeck A/S | H20170384 | 10mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001010478996 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223282 | 20mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020101444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213598 | 10mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001020101523 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20213844 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020102016 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223237 | 10mg(以伏硫西汀计) | Not stated by source | XN06AXF704A001020102770 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243148 | 5mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001020104127 | NHSA |
| 北大医药股份有限公司 | 国药准字H20249357 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020109586 | NHSA |
| 中山万汉制药有限公司 | 国药准字H20253191 | 10mg (按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020109920 | NHSA |
| H.Lundbeck A/S | H20170381 | 5mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001020178996 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255195 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020184207 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20223282 | 20mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020201444 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213598 | 10mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001020201523 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20213844 | 10mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020202016 | NHSA |
| 中山万汉制药有限公司 | 国药准字H20253191 | 10mg (按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020209920 | NHSA |
| H.Lundbeck A/S | H20170381 | 5mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001020278996 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255195 | 10mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001020284207 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213598 | 10mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001020301523 | NHSA |
| H.Lundbeck A/S | H20170382 | 5mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001020378996 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20213598 | 10mg(按C18H22N2S计) | Not stated by source | XN06AXF704A001020401523 | NHSA |
| H.Lundbeck A/S | H20170382 | 5mg(以C18H22N2S计) | Not stated by source | XN06AXF704A001020478996 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20237133 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001030101444 | NHSA |
| 北大医药股份有限公司 | 国药准字H20249358 | 20mg(以C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001030109586 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20237133 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001030201444 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20237133 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001030301444 | NHSA |
| 江苏豪森药业集团有限公司 | 国药准字H20237133 | 5mg(按C₁₈H₂₂N₂S计) | Not stated by source | XN06AXF704A001030401444 | 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: 8 filings and 5 distinct first applicants.
Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东新时代药业有限公司 | CYHS2601752 | Generic | 2026/07/21 | Not stated by source | CDE |
| 云鹏医药集团有限公司 | CYHS2504393 | Generic | 2025/12/25 | Not stated by source | CDE |
| 马应龙药业集团股份有限公司 | CYHS2504370 | Generic | 2025/12/24 | Not stated by source | CDE |
| 马应龙药业集团股份有限公司 | CYHS2504369 | Generic | 2025/12/24 | Not stated by source | CDE |
| 上海谷方盟医药科技有限公司;浙江海翔药业股份有限公司 | CYHS2503642 | Generic | 2025/10/14 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602652 | Generic | 2026/10/29 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602651 | Generic | 2026/10/29 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602650 | Generic | 2026/10/29 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东新时代药业有限公司 | CYHS2601752 | Generic | 2026/07/21 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602652 | Generic | 2026/10/29 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602651 | Generic | 2026/10/29 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHS2602650 | Generic | 2026/10/29 | Not stated by source | CDE |
API registrations
Non-component matches: 26 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 氢溴酸伏硫西汀 | 浙江天台药业股份有限公司 | Y20260000296 | I | Exact ingredient | 2026/04/29 | CDE |
| 乳酸伏硫西汀 | 四川新开元制药有限公司 | Y20250000993 | I | Salt-normalized ingredient | 2025/10/29 | CDE |
| 氢溴酸伏硫西汀 | 浙江海翔川南药业有限公司 | Y20250000711 | I | Exact ingredient | 2025/07/22 | CDE |
| 氢溴酸伏硫西汀 | 浙江乐普药业股份有限公司 | Y20250000384 | A | Exact ingredient | 2026/09/11 | CDE |
| 氢溴酸伏硫西汀 | 华润双鹤湘中药业（湖南）有限公司 | Y20250000126 | A | Exact ingredient | 2026/09/29 | CDE |
| 氢溴酸伏硫西汀 | 浙江华海建诚药业有限公司 | Y20240001365 | A | Exact ingredient | 2026/08/06 | CDE |
| 氢溴酸伏硫西汀 | 山东新时代药业有限公司 | Y20240001098 | A | Exact ingredient | 2026/06/24 | CDE |
| 氢溴酸伏硫西汀 | 四川仁安药业有限责任公司 | Y20240000098 | A | Exact ingredient | 2026/09/16 | CDE |
| 氢溴酸伏硫西汀 | 安徽金太阳生化药业有限公司 | Y20240000117 | A | Exact ingredient | 2025/11/19 | CDE |
| 氢溴酸伏硫西汀 | 浙江乐普药业股份有限公司 | Y20230001182 | A | Exact ingredient | 2025/09/04 | CDE |
| 氢溴酸伏硫西汀 | 浙江九洲药业股份有限公司 | Y20230001011 | A | Exact ingredient | 2025/11/02 | CDE |
| 氢溴酸伏硫西汀 | 江苏恩华药业股份有限公司 | Y20230000789 | A | Exact ingredient | 2025/01/23 | CDE |
| 氢溴酸伏硫西汀 | 石家庄龙泽制药股份有限公司 | Y20230000555 | A | Exact ingredient | 2026/01/07 | CDE |
| 氢溴酸伏硫西汀 | 湖南洞庭药业股份有限公司 | Y20230000195 | A | Exact ingredient | 2024/11/07 | CDE |
| 氢溴酸伏硫西汀 | 浙江精进药业有限公司 | Y20230000034 | A | Exact ingredient | 2026/01/05 | CDE |
| 氢溴酸伏硫西汀 | 北大医药股份有限公司 | Y20230000027 | A | Exact ingredient | 2024/07/17 | CDE |
| 氢溴酸伏硫西汀 | 福建省福抗药业股份有限公司 | Y20220000989 | A | Exact ingredient | 2025/10/10 | CDE |
| 氢溴酸伏硫西汀 | 千辉药业（安徽）有限责任公司 | Y20220000103 | A | Exact ingredient | 2024/01/25 | CDE |
| 氢溴酸伏硫西汀 | 河北广祥制药有限公司 | Y20220000116 | A | Exact ingredient | 2025/02/18 | CDE |
| 氢溴酸伏硫西汀 | 山东辰龙药业有限公司 | Y20220000238 | A | Exact ingredient | 2025/07/09 | CDE |
| 氢溴酸伏硫西汀 | 山东朗诺制药有限公司 | Y20220000220 | A | Exact ingredient | 2024/10/29 | CDE |
| 氢溴酸伏硫西汀 | 中山万汉制药有限公司 | Y20210001265 | A | Exact ingredient | 2026/02/07 | CDE |
| 氢溴酸伏硫西汀 | 山东锐顺药业有限公司 | Y20210001276 | A | Exact ingredient | 2024/05/09 | CDE |
| 氢溴酸伏硫西汀 | Hetero Labs Limited | Y20200001223 | A | Exact ingredient | 2026/03/01 | CDE |
| 氢溴酸伏硫西汀 | 吉林汇康制药有限公司 | Y20200000737 | A | Exact ingredient | 2022/10/28 | CDE |
| 氢溴酸伏硫西汀 | 四川仁安药业有限责任公司 | Y20200000572 | A | Exact ingredient | 2026/05/06 | CDE |
| 氢溴酸伏硫西汀 | 重庆博腾制药科技股份有限公司 | Y20200000505 | A | Exact ingredient | 2026/04/30 | CDE |
| 氢溴酸伏硫西汀 | 四川弘远药业有限公司 | Y20200000548 | A | Exact ingredient | 2026/03/17 | CDE |
| 氢溴酸伏硫西汀 | 江苏豪森药业集团有限公司 | Y20190021303 | A | Exact ingredient | 2026/09/15 | CDE |
| 氢溴酸伏硫西汀 | 连云港润众制药有限公司 | Y20190000584 | A | Exact ingredient | 2026/02/13 | CDE |
| 氢溴酸伏硫西汀 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20180001103 | A | Exact ingredient | 2024/08/26 | CDE |
| 氢溴酸伏硫西汀 | 云鹏医药集团有限公司 | Y20260000905 | I | Exact ingredient | 2026/11/09 | 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.
-
2026/10/29Accepted
-
2026/10/29Accepted
-
2026/10/29Accepted
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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