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Trazodone Hydrochloride Sustained-release Tablets

As 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

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

Ingredient cross-list details ↗

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202649562026/06/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202649572026/06/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jewim Pharmaceutical (Shandong) Co., Ltd.Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202649792026/06/23150mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202639072026/04/07150mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202639082026/04/0775mgGeneric approved under the new chemical-drug registration classificationCDE
Shenzhen Shi Fan Gu Pharma Co., Ltd. romanizedJilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized国药准字H202554892025/09/16See sourceNot stated by sourceCDE

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: 8 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263908See sourceCategory BXN06AXQ113A010010101503NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20264979See sourceCategory BXN06AXQ113A010010104111NHSA
AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A.国药准字HJ2020005175mgCategory BXN06AXQ113A010010182987NHSA
Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized国药准字H20255489See sourceCategory BXN06AXQ113A010010183251NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20264956See sourceCategory BXN06AXQ113A010010183549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263908See sourceCategory BXN06AXQ113A010010201503NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20264979See sourceCategory BXN06AXQ113A010010204111NHSA
AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A.国药准字HJ2020005175mgCategory BXN06AXQ113A010010282987NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20264956See sourceCategory BXN06AXQ113A010010283549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263908See sourceCategory BXN06AXQ113A010010301503NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20264979See sourceCategory BXN06AXQ113A010010304111NHSA
AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A.国药准字HJ2020005175mgCategory BXN06AXQ113A010010382987NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263908See sourceCategory BXN06AXQ113A010010401503NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263908See sourceCategory BXN06AXQ113A010010501503NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263907See sourceCategory BXN06AXQ113A010020101503NHSA
AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A.国药准字HJ20200052150mgCategory BXN06AXQ113A010020182987NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20264957See sourceCategory BXN06AXQ113A010020183549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263907See sourceCategory BXN06AXQ113A010020201503NHSA
AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A.国药准字HJ20200052150mgCategory BXN06AXQ113A010020282987NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20264957See sourceCategory BXN06AXQ113A010020283549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263907See sourceCategory BXN06AXQ113A010020301503NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20264957See sourceCategory BXN06AXQ113A010020383549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263907See sourceCategory BXN06AXQ113A010020401503NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20263907See sourceCategory BXN06AXQ113A010020501503NHSA

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: 20 filings and 15 distinct first applicants.

Generic 20

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCYHS2600176Generic2026/01/14Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602191Generic2026/09/02Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602190Generic2026/09/02Not stated by sourceCDE
Nan Tong Lian Ya Pharma Co., Ltd. romanizedCYHS2601183Generic2026/05/20Not stated by sourceCDE
Hebei Long Hai Pharma Co., Ltd. romanizedCYHS2601909Generic2026/08/05Not stated by sourceCDE
Beijing Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601665Generic2026/07/13Not stated by sourceCDE
Zhao Ke Pharma (Guangzhou) Co., Ltd. romanizedCYHS2601349Generic2026/06/09Not stated by sourceCDE
Zhao Ke Pharma (Guangzhou) Co., Ltd. romanizedCYHS2601348Generic2026/06/09Not stated by sourceCDE
Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanizedCYHS2601039Generic2026/05/08Not stated by sourceCDE
Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanizedCYHS2601038Generic2026/05/08Not stated by sourceCDE
Shenyang Xin Rui Pharmaceutical Co., Ltd. romanizedCYHS2600444Generic2026/02/11Not stated by sourceCDE
Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanizedCYHS2504439Generic2025/12/27Not stated by sourceCDE
Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanizedCYHS2503449Generic2025/09/18Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2503145Generic2025/08/27Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2503144Generic2025/08/27Not stated by sourceCDE
Hefei Li Cheng Pharma Co., Ltd. romanizedCYHS2503001Generic2025/08/16Not stated by sourceCDE
Beijing SL Pharmaceutical Co., Ltd.CYHS2502786Generic2025/08/02Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS2502782Generic2025/08/02Not stated by sourceCDE
Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS2502179Generic2025/06/18Not stated by sourceCDE
Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS2502178Generic2025/06/18Not stated by sourceCDE
New generic filings in 2026

Loaded records: 11 filings and 8 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCYHS2600176Generic2026/01/14Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602191Generic2026/09/02Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602190Generic2026/09/02Not stated by sourceCDE
Nan Tong Lian Ya Pharma Co., Ltd. romanizedCYHS2601183Generic2026/05/20Not stated by sourceCDE
Hebei Long Hai Pharma Co., Ltd. romanizedCYHS2601909Generic2026/08/05Not stated by sourceCDE
Beijing Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601665Generic2026/07/13Not stated by sourceCDE
Zhao Ke Pharma (Guangzhou) Co., Ltd. romanizedCYHS2601349Generic2026/06/09Not stated by sourceCDE
Zhao Ke Pharma (Guangzhou) Co., Ltd. romanizedCYHS2601348Generic2026/06/09Not stated by sourceCDE
Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanizedCYHS2601039Generic2026/05/08Not stated by sourceCDE
Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanizedCYHS2601038Generic2026/05/08Not stated by sourceCDE
Shenyang Xin Rui Pharmaceutical Co., Ltd. romanizedCYHS2600444Generic2026/02/11Not stated by sourceCDE
API registrations

Non-component matches: 8 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸曲唑酮 · No verified English nameHefei Li Fang Pharmaceutical Co., Ltd. romanizedY20260000741IExact ingredient2026/08/21CDE
盐酸曲唑酮 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20260000137IExact ingredient2026/03/03CDE
盐酸曲唑酮 · No verified English nameShandong An Xin Pharmaceutical Co., Ltd. romanizedY20250000875IExact ingredient2025/11/04CDE
盐酸曲唑酮 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20250000868IExact ingredient2025/08/26CDE
盐酸曲唑酮 · No verified English nameZhi En Bio Technology Co., Ltd. romanizedY20250000281IExact ingredient2025/03/26CDE
盐酸曲唑酮 · No verified English nameGranules India Limited. Unit - IV romanizedY20240001042IExact ingredient2024/11/18CDE
盐酸曲唑酮 · No verified English nameArene Life Sciences Private LimitedY20240000118IExact ingredient2024/07/31CDE
盐酸曲唑酮 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20240000132AExact ingredient2026/09/12CDE
盐酸曲唑酮 · No verified English nameHunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY20230001003AExact ingredient2026/06/02CDE
盐酸曲唑酮 · No verified English nameMedilux Laboratories Pvt. Ltd.Y20220000900AExact ingredient2026/09/16CDE
盐酸曲唑酮 · No verified English nameAZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPAY20220000333AExact ingredient2025/09/15CDE
盐酸曲唑酮 · No verified English nameMatrix Pharmacorp Private LimitedY20210000921AExact ingredient2026/09/16CDE
盐酸曲唑酮 · No verified English namePiramal Pharma LimitedY20210000635AExact ingredient2023/08/14CDE
盐酸曲唑酮 · No verified English nameChangzhou Hua Sheng Pharmaceutical Co., Ltd. romanizedY20190004670AExact ingredient2025/07/24CDE
盐酸曲唑酮 · No verified English nameShenyang Fu Ning Pharma Co., Ltd. romanizedY20190002723AExact ingredient2024/07/03CDE
盐酸曲唑酮 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20260000948IExact ingredient2026/11/09CDE

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.

  1. 2026/11/03Marketing application approved

    Hua Yi Tai Kang Pharma Co., Ltd. romanized

    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 ↗
  2. 2026/09/02Accepted

    Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

    CYHS2602191

    Fact date: 2026/09/02 · Site observation date: 2026/10/21

    View source ↗
  3. 2026/09/02Accepted

    Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

    CYHS2602190

    Fact date: 2026/09/02 · Site observation date: 2026/10/21

    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

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: 2026/11/13 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.

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.

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