Monthly
US$200
Billed every month
Sign in to subscribeAs of 13 November 2026, for Trazodone Hydrochloride Sustained-release Tablets, 20 applications are listed as under review at China's CDE; 8 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 3 of 3 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Sustained-release Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| OLEPTRO | ANGELINI PHARMA INC | NDA 022411 · Product no. 001, 002 | TABLET, EXTENDED RELEASE | ORAL | DISCONTINUED | 2010/02/02 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| RALDESY | KAMAT PHARMATECH LLC | NDA 218637 · Product no. 001 | SOLUTION | ORAL | HUMAN PRESCRIPTION DRUG | 2024/11/26 |
| DESYREL | PRAGMA PHARMACEUTICALS LLC | NDA 018207 · Product no. 001, 002 | TABLET | ORAL | DISCONTINUED | Approved prior to 1982 (exact date not listed) |
| DESYREL | PRAGMA PHARMACEUTICALS LLC | NDA 018207 · Product no. 003 | TABLET | ORAL | DISCONTINUED | 1985/03/25 |
| DESYREL | PRAGMA PHARMACEUTICALS LLC | NDA 018207 · Product no. 004 | TABLET | ORAL | DISCONTINUED | 1988/11/07 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979 | 2026/06/23 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | 2026/04/07 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | 2026/04/07 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20255489 | 2025/09/16 | See source | Not stated by source | 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.
Loaded records: 8 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | See source | Category B | XN06AXQ113A010010101503 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979 | See source | Category B | XN06AXQ113A010010104111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B | XN06AXQ113A010010182987 | NHSA |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H20255489 | See source | Category B | XN06AXQ113A010010183251 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956 | See source | Category B | XN06AXQ113A010010183549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | See source | Category B | XN06AXQ113A010010201503 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979 | See source | Category B | XN06AXQ113A010010204111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B | XN06AXQ113A010010282987 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956 | See source | Category B | XN06AXQ113A010010283549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | See source | Category B | XN06AXQ113A010010301503 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979 | See source | Category B | XN06AXQ113A010010304111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B | XN06AXQ113A010010382987 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | See source | Category B | XN06AXQ113A010010401503 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908 | See source | Category B | XN06AXQ113A010010501503 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | See source | Category B | XN06AXQ113A010020101503 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052 | 150mg | Category B | XN06AXQ113A010020182987 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957 | See source | Category B | XN06AXQ113A010020183549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | See source | Category B | XN06AXQ113A010020201503 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052 | 150mg | Category B | XN06AXQ113A010020282987 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957 | See source | Category B | XN06AXQ113A010020283549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | See source | Category B | XN06AXQ113A010020301503 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957 | See source | Category B | XN06AXQ113A010020383549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | See source | Category B | XN06AXQ113A010020401503 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907 | See source | Category B | XN06AXQ113A010020501503 | 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.
Loaded records: 20 filings and 15 distinct first applicants.
Generic 20
Loaded records: 11 filings and 8 distinct first applicants.
Non-component matches: 8 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸曲唑酮 · No verified English name | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20260000741 | I | Exact ingredient | 2026/08/21 | CDE |
| 盐酸曲唑酮 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20260000137 | I | Exact ingredient | 2026/03/03 | CDE |
| 盐酸曲唑酮 · No verified English name | Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20250000875 | I | Exact ingredient | 2025/11/04 | CDE |
| 盐酸曲唑酮 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20250000868 | I | Exact ingredient | 2025/08/26 | CDE |
| 盐酸曲唑酮 · No verified English name | Zhi En Bio Technology Co., Ltd. romanized | Y20250000281 | I | Exact ingredient | 2025/03/26 | CDE |
| 盐酸曲唑酮 · No verified English name | Granules India Limited. Unit - IV romanized | Y20240001042 | I | Exact ingredient | 2024/11/18 | CDE |
| 盐酸曲唑酮 · No verified English name | Arene Life Sciences Private Limited | Y20240000118 | I | Exact ingredient | 2024/07/31 | CDE |
| 盐酸曲唑酮 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000132 | A | Exact ingredient | 2026/09/12 | CDE |
| 盐酸曲唑酮 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20230001003 | A | Exact ingredient | 2026/06/02 | CDE |
| 盐酸曲唑酮 · No verified English name | Medilux Laboratories Pvt. Ltd. | Y20220000900 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸曲唑酮 · No verified English name | AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA | Y20220000333 | A | Exact ingredient | 2025/09/15 | CDE |
| 盐酸曲唑酮 · No verified English name | Matrix Pharmacorp Private Limited | Y20210000921 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸曲唑酮 · No verified English name | Piramal Pharma Limited | Y20210000635 | A | Exact ingredient | 2023/08/14 | CDE |
| 盐酸曲唑酮 · No verified English name | Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | Y20190004670 | A | Exact ingredient | 2025/07/24 | CDE |
| 盐酸曲唑酮 · No verified English name | Shenyang Fu Ning Pharma Co., Ltd. romanized | Y20190002723 | A | Exact ingredient | 2024/07/03 | CDE |
| 盐酸曲唑酮 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20260000948 | 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.
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.
CYHS2502426 · 国药准字H20266455
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 91 ↗CYHS2602191
Fact date: 2026/09/02 · Site observation date: 2026/10/21
View source ↗CYHS2602190
Fact date: 2026/09/02 · Site observation date: 2026/10/21
View source ↗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.
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.
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.
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: 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.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
Sign in to subscribeUS$540
Billed every three months
US$180 per month
Sign in to subscribeUS$1,920
Billed every year
US$160 per month
Sign in to subscribeSeparate one-time purchase
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.
Billed by Creem, our merchant of record · Terms · Refund policy