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Budesonide Nasal Spray

As of 13 November 2026, for Budesonide Nasal Spray, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

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

Listed in the US FDA Orange Book as RHINOCORT ALLERGY (NDA 020746, KENVUE BRANDS LLC).

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 5 of 10 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: Nasal Spray. 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
RHINOCORT ALLERGY KENVUE BRANDS LLC NDA 020746 · Product no. 003 SPRAY, METERED NASAL HUMAN OTC DRUG 2015/03/23

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
PULMICORT RESPULES ASTRAZENECA PHARMACEUTICALS LP NDA 020929 · Product no. 001, 002, 003 SUSPENSION INHALATION HUMAN PRESCRIPTION DRUG 2000/08/08
ENTOCORT EC PADAGIS US LLC NDA 021324 · Product no. 001 CAPSULE, DELAYED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2001/10/02
PULMICORT FLEXHALER CHEPLAPHARM ARZNEIMITTEL GMBH NDA 021949 · Product no. 001, 002 POWDER, METERED INHALATION HUMAN PRESCRIPTION DRUG 2006/07/12
UCERIS SALIX PHARMACEUTICALS INC NDA 203634 · Product no. 001 TABLET, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2013/01/14
UCERIS SALIX PHARMACEUTICALS INC NDA 205613 · Product no. 001 AEROSOL, FOAM RECTAL HUMAN PRESCRIPTION DRUG 2014/10/07

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: 1 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
McNeil Sweden ABAstraZeneca ABH20171309;H201713102002/02/21See sourceImported originator drugCDE
McNeil Sweden ABAstraZeneca ABH20171311;H201713122002/02/21See sourceImported originator drugCDE

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: 13 distinct approval numbers and 4 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
McNeil Sweden AB国药准字J20180024See sourceCategory BXR01ADB165L025010100734NHSA
Yuan Da Jiu He (Jiangxi) Pharma Co., Ltd. romanized国药准字H20234500See sourceCategory BXR01ADB165L025010105402NHSA
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字J20190031See sourceCategory BXR01ADB165L025010110427NHSA
McNeil Sweden AB国药准字HJ20171309See sourceCategory BXR01ADB165L025010179321NHSA
Sichuan Pu Rui Te Pharma Co., Ltd. romanized国药准字H20234511See sourceCategory BXR01ADB165L025010181590NHSA
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20181007See sourceCategory BXR01ADB165L025010182195NHSA
McNeil Sweden ABH20171310See sourceCategory BXR01ADB165L025010279321NHSA
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20191008See sourceCategory BXR01ADB165L025010282195NHSA
McNeil Sweden AB国药准字J20180023See sourceCategory BXR01ADB165L025020100734NHSA
Yuan Da Jiu He (Jiangxi) Pharma Co., Ltd. romanized国药准字H20234507See sourceCategory BXR01ADB165L025020105402NHSA
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字J20190031See sourceCategory BXR01ADB165L025020110427NHSA
McNeil Sweden AB国药准字HJ20171311See sourceCategory BXR01ADB165L025020179321NHSA
Sichuan Pu Rui Te Pharma Co., Ltd. romanized国药准字H20234512See sourceCategory BXR01ADB165L025020181590NHSA
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20181007See sourceCategory BXR01ADB165L025020182195NHSA
McNeil Sweden ABH20171312See sourceCategory BXR01ADB165L025020279321NHSA

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: 3 filings and 2 distinct first applicants.

Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jewim Pharmaceutical (Shandong) Co., Ltd.CYHS2602441Generic2026/10/08Not stated by sourceCDE
Zhang Feng Pharma Co., Ltd. romanizedCYHS2600273Generic2026/01/24Not stated by sourceCDE
Zhang Feng Pharma Co., Ltd. romanizedCYHS2600272Generic2026/01/24Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jewim Pharmaceutical (Shandong) Co., Ltd.CYHS2602441Generic2026/10/08Not stated by sourceCDE
Zhang Feng Pharma Co., Ltd. romanizedCYHS2600273Generic2026/01/24Not stated by sourceCDE
Zhang Feng Pharma Co., Ltd. romanizedCYHS2600272Generic2026/01/24Not stated by sourceCDE
API registrations

Non-component matches: 21 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
布地奈德 · No verified English nameXu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanizedY20260000850IExact ingredient2026/10/14CDE
布地奈德 · No verified English nameAo Rui Te Pharma Co., Ltd. romanizedY20250000390AExact ingredient2026/10/14CDE
布地奈德 · No verified English nameZhejiang Shen Zhou Pharma Co., Ltd. romanizedY20250000179AExact ingredient2026/09/29CDE
布地奈德 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20240000238AExact ingredient2025/07/25CDE
布地奈德 · No verified English nameAspen Oss B.V.Y20230000013AExact ingredient2025/08/06CDE
布地奈德 · No verified English nameXin Xiang Hai Bin Pharma Co., Ltd. romanizedY20220001161AExact ingredient2024/05/29CDE
布地奈德 · No verified English nameBo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanizedY20220001042AExact ingredient2026/07/08CDE
布地奈德 · No verified English nameBo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanizedY20220001041AExact ingredient2024/12/27CDE
布地奈德 · No verified English nameShandong Si Rui Pharma Co., Ltd. romanizedY20220000980AExact ingredient2026/08/22CDE
布地奈德 · No verified English nameHebei Chuang Jian Pharma Co., Ltd. romanizedY20220000613AExact ingredient2024/04/25CDE
布地奈德 · No verified English nameXin Xiang Hai Bin Pharma Co., Ltd. romanizedY20220000235AExact ingredient2024/01/16CDE
布地奈德 · No verified English nameINDUSTRIALE CHIMICA SRLY20220000028AExact ingredient2025/01/28CDE
布地奈德 · No verified English nameFARMABIOS S.P.A.Y20210001146AExact ingredient2024/12/31CDE
布地奈德 · No verified English nameFARMABIOS S.P.A.Y20210000328IExact ingredient2021/10/27CDE
布地奈德 · No verified English nameAvik Pharmaceutical LtdY20210000776AExact ingredient2025/01/15CDE
布地奈德 · No verified English nameSicor Societa’ Italiana Corticosteroidi S.R.L.Y20210000494IExact ingredient2021/07/23CDE
布地奈德 · No verified English nameNewchem S.p.A.Y20200001161AExact ingredient2025/06/21CDE
布地奈德 · No verified English nameHenan Li Hua Pharmaceutical Co., Ltd. romanizedY20200001406AExact ingredient2024/02/24CDE
布地奈德 · No verified English nameSICOR DE MEXICO, S.A. de C.V.Y20210000111IExact ingredient2023/07/04CDE
布地奈德 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20190009886AExact ingredient2024/09/03CDE
布地奈德 · No verified English nameJin Yao Pharma Co., Ltd. romanizedY20190008852AExact ingredient2026/01/24CDE
布地奈德 · No verified English nameLu Nan Bei Te Pharmaceutical Co., Ltd. romanizedY20190003690AExact ingredient2025/03/11CDE
布地奈德 · No verified English nameShanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanizedY20190001490AExact ingredient2025/01/23CDE
布地奈德 · No verified English nameCURIA SPAIN S.A.U.Y20190000645IExact ingredient2023/11/20CDE
布地奈德 · No verified English nameCURIA SPAIN S.A.U.Y20190000457IExact ingredient2022/06/22CDE
布地奈德 · No verified English nameMINAKEMY20180001668AExact ingredient2026/06/13CDE
布地奈德 · No verified English nameAspen Oss B.V.Y20180001131IExact ingredient2018/12/27CDE
布地奈德 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20180000713IExact ingredient2018/07/25CDE
布地奈德 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20170001463AExact ingredient2025/04/16CDE
布地奈德 · No verified English nameVAMSI LABS LTD.Y20170000975AExact ingredient2025/07/20CDE
布地奈德 · No verified English nameLian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY20170000971AExact ingredient2023/03/24CDE

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. 2026/10/08Accepted

    Jewim Pharmaceutical (Shandong) Co., Ltd.

    CYHS2602441

    Fact date: 2026/10/08 · 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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