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Dexmethylphenidate Hydrochloride Tablets

As of 13 November 2026, for Dexmethylphenidate Hydrochloride Tablets, 1 application is listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.

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

Listed in the US FDA Orange Book as FOCALIN (NDA 021278, SANDOZ INC).

Last 90 days: Accepted: 1 application

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

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 2 of 2 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: 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
FOCALIN SANDOZ INC NDA 021278 · Product no. 001, 002, 003 TABLET ORAL HUMAN PRESCRIPTION DRUG 2001/11/13

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
FOCALIN XR SANDOZ INC NDA 021802 · Product no. 001, 002, 003 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2005/05/26
FOCALIN XR SANDOZ INC NDA 021802 · Product no. 004 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2006/08/01
FOCALIN XR SANDOZ INC NDA 021802 · Product no. 005 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2009/10/23
FOCALIN XR SANDOZ INC NDA 021802 · Product no. 006 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2010/08/11
FOCALIN XR SANDOZ INC NDA 021802 · Product no. 007, 008 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2011/04/21

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: 0 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 0 distinct approval numbers and 0 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 1 filings and 1 distinct first applicants.

Generic 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHL2600095Generic2026/09/04Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHL2600095Generic2026/09/04Not stated by sourceCDE
Henan Zhong Shuai Pharma Co., Ltd. romanizedCYHL2600070Generic2026/06/09Not stated by sourceCDE
API registrations

Non-component matches: 2 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸右哌甲酯 · No verified English nameGuo Yao Group Guo Rui Pharma Co., Ltd. romanizedY20260000635IExact ingredient2026/08/05CDE
盐酸右哌甲酯 · No verified English nameYi Chang Ren Fu Pharma Co., Ltd. romanizedY20250001457IExact ingredient2026/01/08CDE
盐酸右哌甲酯 · No verified English nameGuo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanizedY20250001440IExact ingredient2025/12/30CDE
盐酸右哌甲酯 · No verified English nameHefei Li Fang Pharmaceutical Co., Ltd. romanizedY20240001340AExact ingredient2026/09/20CDE
盐酸右哌甲酯 · No verified English nameHenan Zhong Shuai Pharma Co., Ltd. romanizedY20200001310AExact ingredient2025/02/07CDE

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. 2026/09/04Accepted

    Guo Yao Group Guo Rui Pharma Co., Ltd. romanized

    CYHL2600095

    Fact date: 2026/09/04 · 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

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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