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Calcitriol Oral Solution

As of 13 November 2026, for Calcitriol Oral Solution, 4 applications are listed as under review at China's CDE; 3 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 ROCALTROL (NDA 021068, ESJAY PHARMA LLC).

Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications

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 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: Oral Solution. 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
ROCALTROL ESJAY PHARMA LLC NDA 021068 · Product no. 001 SOLUTION ORAL HUMAN PRESCRIPTION DRUG 1998/11/20

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
ROCALTROL ESJAY PHARMA LLC NDA 018044 · Product no. 001, 002 CAPSULE ORAL HUMAN PRESCRIPTION DRUG Approved prior to 1982 (exact date not listed)
VECTICAL GALDERMA LABORATORIES LP NDA 022087 · Product no. 001 OINTMENT TOPICAL HUMAN PRESCRIPTION DRUG 2009/01/23
CALCIJEX ABBVIE INC NDA 018874 · Product no. 001, 002 INJECTABLE INJECTION DISCONTINUED 1986/09/25

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: 3 distinct approval numbers and 3 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H2026355015ml:15μgCategory BXA11CCG111X001010105816NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H2023371515ml:15μgCategory BXA11CCG111X001010104036NHSA
Xinjiang Te Feng Pharma Co., Ltd. romanized国药准字H2023373910ml:10μgCategory BXA11CCG111X001010105999NHSA

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: 4 filings and 4 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanizedCYHS2503942Generic2025/11/13Not stated by sourceCDE
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanizedCYHS2602431Generic2026/09/29Not stated by sourceCDE
Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanizedCYHS2600523Generic2026/02/25Not stated by sourceCDE
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS2602719Generic2026/11/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanizedCYHS2602431Generic2026/09/29Not stated by sourceCDE
Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanizedCYHS2600523Generic2026/02/25Not stated by sourceCDE
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS2602719Generic2026/11/05Not stated by sourceCDE
API registrations

Non-component matches: 10 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
骨化三醇 · No verified English nameGansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanizedY20230000587AExact ingredient2024/12/13CDE
骨化三醇 · No verified English nameMicroBiopharm Japan Co.,Ltd.Y20220000293AExact ingredient2025/09/23CDE
骨化三醇 · No verified English nameNanjing Hai Jing Pharma Co., Ltd., Nanjing Hai Jing Pharma Co., Ltd. romanizedY20220000833AExact ingredient2026/06/02CDE
骨化三醇 · No verified English nameCerbios-Pharma SAY20200001217AExact ingredient2023/05/08CDE
骨化三醇 · No verified English nameNanjing Hai Rong Pharmaceutical Co., Ltd. romanizedY20210000028AExact ingredient2025/04/04CDE
骨化三醇 · No verified English nameSichuan Gowell Pharmaceutical Co., Ltd.Y20200000975AExact ingredient2026/04/01CDE
骨化三醇 · No verified English nameFormosa Laboratories, Inc.Y20190021431AExact ingredient2026/05/20CDE
骨化三醇 · No verified English nameQingdao Guo Xin Pharmaceutical Co., Ltd. romanizedY20190009407AExact ingredient2025/01/15CDE
骨化三醇 · No verified English nameMicroBiopharm Japan Co.,Ltd.Y20190008975AExact ingredient—CDE
骨化三醇 · No verified English nameCarbogen Amcis B.V.Y20180000989AExact ingredient2026/10/11CDE
骨化三醇 · No verified English nameZheng Da Pharmaceutical (Qingdao) Co., Ltd. romanizedY20180000361IExact ingredient2018/10/22CDE
骨化三醇 · No verified English nameZhengzhou Tai Feng Pharmaceutical Co., Ltd. romanizedY20170001284AExact ingredient2023/05/11CDE

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. 2026/11/05Accepted

    Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized

    CYHS2602719

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  2. 2026/10/20Marketing application approved

    Henan Tai Feng Bio Technology Co., Ltd. romanized

    CYHS2500040 · 国药准字H20266373

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    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 20 ↗
  3. 2026/09/29Accepted

    Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized

    CYHS2602431

    Fact date: 2026/09/29 · 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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