Monthly
US$200
Billed every month
Methylprednisolone Sodium Succinate for injection(注射用甲泼尼龙琥珀酸钠)
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 holders11View records ↓
Under-review filings12View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers34View records ↓
API companies with A status1View records ↓
Chemical-drug catalogue
Loaded records: 11 holders; 9 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 常州四药制药有限公司 | 常州四药制药有限公司 | 国药准字H20173357 | 2025/12/11 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 津药和平（天津）制药有限公司 | 津药和平（天津）制药有限公司 | 国药准字H20247165 | 2024/07/15 | 20mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 瀚晖制药有限公司 | 瀚晖制药有限公司 | 国药准字H20237172 | 2023/12/11 | 40mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 瀚晖制药有限公司 | 瀚晖制药有限公司 | 国药准字H20237173 | 2023/12/11 | 500mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 福安药业集团湖北人民制药有限公司 | 福安药业集团湖北人民制药有限公司 | 国药准字H20237074 | 2023/07/05 | 20mg(按C22H30O5计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南合瑞制药股份有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20233369 | 2023/03/24 | 500mg（按C22H30O5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 |
| 海南合瑞制药股份有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20233368 | 2023/03/24 | 40mg（按C22H30O5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 |
| 福安药业集团湖北人民制药有限公司 | 福安药业集团湖北人民制药有限公司 | 国药准字H20183041 | 2023/02/23 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 重庆莱美药业股份有限公司 | 重庆莱美药业股份有限公司 | 国药准字H20203329 | 2022/01/30 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 重庆华邦制药有限公司 | 重庆华邦制药有限公司 | 国药准字H20143136 | 2021/10/11 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天津金耀药业有限公司 | 天津金耀药业有限公司 | 国药准字H20103047 | 2021/05/31 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 重庆华邦制药有限公司 | 重庆华邦制药有限公司 | 国药准字H20153195 | 2021/05/25 | 500mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天津金耀药业有限公司 | 天津金耀药业有限公司 | 国药准字H20217036 | 2021/05/10 | 125mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天津金耀药业有限公司 | 天津金耀药业有限公司 | 国药准字H20123319 | 2021/05/10 | 500mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天津金耀药业有限公司 | 天津金耀药业有限公司 | 国药准字H20217037 | 2021/05/10 | 1.0g（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天津金耀药业有限公司 | 天津金耀药业有限公司 | 国药准字H20217038 | 2021/05/10 | 2.0g（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 国药集团容生制药有限公司 | 国药集团容生制药有限公司 | 国药准字H20040845 | 2021/04/16 | 125mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 国药集团容生制药有限公司 | 国药集团容生制药有限公司 | 国药准字H20010098 | 2021/04/16 | 500mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 国药集团容生制药有限公司 | 国药集团容生制药有限公司 | 国药准字H20030727 | 2021/04/16 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 国药集团容生制药有限公司 | 国药集团容生制药有限公司 | 国药准字H20040844 | 2021/04/16 | 250mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 国药集团容生制药有限公司 | 国药集团容生制药有限公司 | 国药准字H20070007 | 2021/04/16 | 20mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 辽宁海思科制药有限公司 | 辽宁海思科制药有限公司 | 国药准字H20133233 | 2021/03/26 | 125mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 辽宁海思科制药有限公司 | 辽宁海思科制药有限公司 | 国药准字H20133234 | 2021/03/26 | 40mg（按C22H30O5计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| PFIZER SA | Pfizer Manufacturing Belgium NV | H20170197 | 1988/09/01 | 40mg | Imported originator drug (进口原研药品) | CDE |
| PFIZER SA | Pfizer Manufacturing Belgium NV | H20170199 | 1988/09/01 | 500mg | 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: 34 distinct approval numbers and 14 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 津药和平(天津)制药有限公司 | 国药准字H20247165 | 20mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001010100874 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H20103047 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010100933 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20153195 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010101003 | NHSA |
| 重庆莱美药业股份有限公司 | 国药准字H20203329 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001010101017 | NHSA |
| 常州四药制药有限公司 | 国药准字H20173357 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001010101389 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20040845 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010103205 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20233368 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010105815 | NHSA |
| 辽宁海思科制药有限公司 | 国药准字H20133233 | 125mg((按C22H30O5计) | Category B (乙) | XH02ABJ061B001010106155 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183040 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010109554 | NHSA |
| 瀚晖制药有限公司 | 国药准字H20237172 | 40mg | Category B (乙) | XH02ABJ061B001010109853 | NHSA |
| PFIZER SA | H20170199 | 500mg | Category B (乙) | XH02ABJ061B001010178729 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H20103047 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010200933 | NHSA |
| 重庆莱美药业股份有限公司 | 国药准字H20203329 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001010201017 | NHSA |
| 常州四药制药有限公司 | 国药准字H20173357 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001010201389 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20233368 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010205815 | NHSA |
| 辽宁海思科制药有限公司 | 国药准字H20133233 | 125mg((按C22H30O5计) | Category B (乙) | XH02ABJ061B001010206155 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H20103047 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001010300933 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20143136 | 40mg(以C22H30O5计) | Category B (乙) | XH02ABJ061B001020101003 | NHSA |
| 重庆莱美药业股份有限公司 | 国药准字H20203238 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020101017 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20040844 | 250mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020103205 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20233369 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020105815 | NHSA |
| 辽宁海思科制药有限公司 | 国药准字H20133234 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020106155 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183039 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020109554 | NHSA |
| 瀚晖制药有限公司 | 国药准字H20237173 | 500mg | Category B (乙) | XH02ABJ061B001020109853 | NHSA |
| PFIZER SA | H20170197 | 40mg | Category B (乙) | XH02ABJ061B001020178729 | NHSA |
| 南光化学制药股份有限公司 | HC20150041 | 250mg | Category B (乙) | XH02ABJ061B001020179066 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20143136 | 40mg(以C22H30O5计) | Category B (乙) | XH02ABJ061B001020201003 | NHSA |
| 重庆莱美药业股份有限公司 | 国药准字H20203238 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020201017 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20233369 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020205815 | NHSA |
| 辽宁海思科制药有限公司 | 国药准字H20133234 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001020206155 | NHSA |
| PFIZER SA | 国药准字HJ20170197 | 40mg | Category B (乙) | XH02ABJ061B001020278729 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20143136 | 40mg(以C22H30O5计) | Category B (乙) | XH02ABJ061B001020301003 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20153195 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001030101003 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20030727 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001030103205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183041 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001030109554 | NHSA |
| PFIZER NV/SA | 国药准字HJ20170199 | 500mg | Category B (乙) | XH02ABJ061B001030178729 | NHSA |
| 南光化学制药股份有限公司 | HC20150042 | 500mg | Category B (乙) | XH02ABJ061B001030179066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20030727 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001030203205 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20030727 | 40mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001040103205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183041 | 40mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001040109554 | NHSA |
| 南光化学制药股份有限公司 | HC20160039 | 40mg | Category B (乙) | XH02ABJ061B001040179066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20040844 | 250mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001040203205 | NHSA |
| 南光化学制药股份有限公司 | HC20160039 | 40mg | Category B (乙) | XH02ABJ061B001040279066 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20160039 | 40mg | Category B (乙) | XH02ABJ061B001040379066 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20160039 | 40mg | Category B (乙) | XH02ABJ061B001040479066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20040845 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001050103205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183040 | 125mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001050109554 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20150040 | 125mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001050179066 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20150040 | 125mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001050279066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20010098 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001060103205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20183039 | 500mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001060109554 | NHSA |
| Nang Kuang Pharmaceutical Co., Ltd | 国药准字HC20150041 | 250mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001060179066 | NHSA |
| Nang Kuang Pharmaceutical Co., Ltd | 国药准字HC20150041 | 250mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001060279066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20070007 | 20mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001070103205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20237074 | 20mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001070109554 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20150042 | 500mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001070179066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20070007 | 20mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001070203205 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20237074 | 20mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001070209554 | NHSA |
| 南光化学制药股份有限公司 | 国药准字HC20150042 | 500mg(按C₂₂H₃₀O₅计) | Category B (乙) | XH02ABJ061B001070279066 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20070007 | 20mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B001070303205 | NHSA |
| 天津金耀药业有限公司 | 国药准字H20123319 | 500mg(以甲泼尼龙C22H30O5计) | Category B (乙) | XH02ABJ061B014010100933 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20070007 | 20mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B014020103205 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20070007 | 20mg(按C22H30O5计) | Category B (乙) | XH02ABJ061B014020203205 | 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: 12 filings and 9 distinct first applicants.
Generic 10 · Import re-registration 1 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京黄龙生物科技有限公司;马鞍山丰原制药有限公司 | CYHS2601437 | Generic | 2026/06/17 | Not stated by source | CDE |
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601822 | Generic | 2026/07/29 | Not stated by source | CDE |
| Nang Kuang Pharmaceutical Co. Ltd;Hainan zhenyuanPharmaceutical Co. Ltd. | JYHZ2600163 | Import re-registration | 2026/07/07 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601473 | Generic | 2026/06/23 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601472 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东达冠医药科技有限公司;烟台东诚北方制药有限公司 | CYHS2600447 | Generic | 2026/02/11 | Not stated by source | CDE |
| 山东新华鲁抗医药有限公司;海南合瑞制药股份有限公司 | CYHS2503641 | Generic | 2025/10/14 | Not stated by source | CDE |
| 重庆莱美药业股份有限公司 | CYHB2501569 | Supplement | 2025/08/08 | Not stated by source | CDE |
| 海南倍特药业有限公司;海南合瑞制药股份有限公司 | CYHS2502446 | Generic | 2025/07/09 | Not stated by source | CDE |
| 海南倍特药业有限公司;海南合瑞制药股份有限公司 | CYHS2502445 | Generic | 2025/07/09 | Not stated by source | CDE |
| 舒美奇成都生物科技有限公司;成都天台山制药股份有限公司 | CYHS2501816 | Generic | 2025/05/20 | Not stated by source | CDE |
| 舒美奇成都生物科技有限公司;成都天台山制药股份有限公司 | CYHS2501815 | Generic | 2025/05/20 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京黄龙生物科技有限公司;马鞍山丰原制药有限公司 | CYHS2601437 | Generic | 2026/06/17 | Not stated by source | CDE |
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601822 | Generic | 2026/07/29 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601473 | Generic | 2026/06/23 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601472 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东达冠医药科技有限公司;烟台东诚北方制药有限公司 | CYHS2600447 | Generic | 2026/02/11 | Not stated by source | CDE |
API registrations
Non-component matches: 1 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 |
|---|---|---|---|---|---|---|
| 甲泼尼龙琥珀酸钠 | 河南利华制药有限公司 | Y20170001669 | A | Exact ingredient | 2024/09/11 | CDE |
| 甲泼尼龙琥珀酸钠 | 西班牙水晶医药公司 | Y20170000199 | I | Exact 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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