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Crisaborole Ointment

As of 13 November 2026, for Crisaborole Ointment, 26 applications are listed as under review at China's CDE; 11 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.

Last 90 days: Accepted: 3 applicationsNo longer listed under review: 3 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 1 of 1 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: Ointment. 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

No listings in this group among the displayed brand names.

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
EUCRISA ANACOR PHARMACEUTICALS INC NDA 207695 · Product no. 001 OINTMENT TOPICAL HUMAN PRESCRIPTION DRUG 2016/12/14

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
Anacor Pharmaceuticals, Inc.Pharmacia and Upjohn Company LLC国药准字HJ202000222020/07/292%Imported 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: 23 distinct approval numbers and 22 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Fu Yuan Pharma Co., Ltd. romanized国药准字H202646502%(30g:0.6g)Category BXD11AHK139F001010100177NHSA
Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized国药准字H202558672%(30g:0.6g)Category BXD11AHK139F001010100340NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202548962%(30g:0.6g)Category BXD11AHK139F001010101503NHSA
Hubei Heng An Fu Lin Pharma Co., Ltd. romanized国药准字H202560132%(30g:0.6g)Category BXD11AHK139F001010101808NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202652042%(30g∶0.6g)Category BXD11AHK139F001010102180NHSA
Ya Bao Pharma Group Co., Ltd. romanized国药准字H202649932%(30g∶0.6g)Category BXD11AHK139F001010102959NHSA
Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized国药准字H202557402%(30g:0.6g)Category BXD11AHK139F001010104522NHSA
Zhejiang AngLiKang Pharmaceutical CO.,LTD.国药准字H202639042%(30g:0.6g)Category BXD11AHK139F001010104606NHSA
Hunan Jiudian Pharmaceutical Co., Ltd国药准字H202641732%(30g:0.6g)Category BXD11AHK139F001010104942NHSA
Hunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H202560482%(30g:0.6g)Category BXD11AHK139F001010105001NHSA
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H202641702%(30g:0.6g)Category BXD11AHK139F001010180537NHSA
Anacor Pharmaceuticals, LLC国药准字HJ202000222%Category BXD11AHK139F001010182999NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H202560152%(30g:0.6g)Category BXD11AHK139F001010183191NHSA
Hebei He Du Pharma Co., Ltd. romanized国药准字H202659982%(30g:0.6g)Category BXD11AHK139F001010183394NHSA
Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized国药准字H202643142%(30g:0.6g)Category BXD11AHK139F001010183544NHSA
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H202553802%(30g:0.6g)Category BXD11AHK139F001010183549NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H202554872%(30g:0.6g)Category BXD11AHK139F001010184221NHSA
Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized国药准字H202644212%(30g:0.6g)Category BXD11AHK139F001010184239NHSA
Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202449792%(30g:0.6g)Category BXD11AHK139F001010184314NHSA
Suzhou Gao Mai Pharma Co., Ltd. romanized国药准字H202643852%(30g:0.6g)Category BXD11AHK139F001010184410NHSA
Hubei Min Kang Pharma Group Co., Ltd. romanized国药准字H202659472%(30g:0.6g)Category BXD11AHK139F001010184564NHSA
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized国药准字H202548922%(60g:1.2g)Category BXD11AHK139F001010184874NHSA
Anacor Pharmaceuticals, LLC国药准字HJ202000222%Category BXD11AHK139F001020182999NHSA
Hubei Min Kang Pharma Group Co., Ltd. romanized国药准字H202659482%(60g:1.2g)Category BXD11AHK139F001020184564NHSA
Anacor Pharmaceuticals, LLC国药准字HJ202000222%Category BXD11AHK139F001030182999NHSA

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: 26 filings and 24 distinct first applicants.

Generic 24 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Haerbin Kui Hua Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.CYHS2503831Generic2025/10/30Not stated by sourceCDE
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedCYHS2601187Generic2026/05/20Not stated by sourceCDE
Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanizedCYHS2502537Generic2025/07/16Not stated by sourceCDE
Suzhou Dong Rui Pharmaceutical Co., Ltd. romanizedCYHS2503518Generic2025/09/25Not stated by sourceCDE
Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanizedCYHS2504411Generic2025/12/26Not stated by sourceCDE
Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanizedCYHS2600855Generic2026/04/14Not stated by sourceCDE
Ha Yao Group Bio Gong Cheng Co., Ltd. romanizedCYHS2601367Generic2026/06/10Not stated by sourceCDE
Hubei Cheng Tian Pharma Co., Ltd. romanizedCYHS2601104Generic2026/05/13Not stated by sourceCDE
Shandong Fang Ming Pharma Group Co., Ltd. romanizedCYHS2600938Generic2026/04/23Not stated by sourceCDE
Ma Ying Long Pharma Group Co., Ltd. romanizedCYHS2600823Generic2026/04/09Not stated by sourceCDE
Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCYHS2600433Generic2026/02/10Not stated by sourceCDE
Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCYHS2600432Generic2026/02/10Not stated by sourceCDE
Haerbin Da Zhong Pharmaceutical Co., Ltd. romanizedCYHS2600431Generic2026/02/10Not stated by sourceCDE
Hubei Ke Yi Pharma Co., Ltd. romanizedCYHS2600243Generic2026/01/21Not stated by sourceCDE
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS2600180Generic2026/01/14Not stated by sourceCDE
Hunan Di Nuo Pharmaceutical Co., Ltd. romanizedCYHS2600094Generic2026/01/08Not stated by sourceCDE
Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanizedCYHS2504438Generic2025/12/27Not stated by sourceCDE
Chongqing Xi Er An Pharma Co., Ltd. romanizedCYHS2504330Generic2025/12/19Not stated by sourceCDE
Jin Hua Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanizedCYHS2504256Generic2025/12/11Not stated by sourceCDE
Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanizedCYHS2504114Generic2025/11/29Not stated by sourceCDE
Yao Da Pharmaceutical Co., Ltd. romanizedCYHS2504104Generic2025/11/28Not stated by sourceCDE
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanizedCYHS2503828Generic2025/10/29Not stated by sourceCDE
You Hua Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCYHS2503633Generic2025/10/11Not stated by sourceCDE
Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanizedCYHS2502633Generic2025/07/22Not stated by sourceCDE
Qilu Pharmaceutical Co., Ltd.CYHB2601976Supplement2026/10/29Not stated by sourceCDE
Qilu Pharmaceutical Co., Ltd.CYHB2601975Supplement2026/10/29Not stated by sourceCDE
New generic filings in 2026

Loaded records: 12 filings and 11 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedCYHS2601187Generic2026/05/20Not stated by sourceCDE
Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanizedCYHS2600855Generic2026/04/14Not stated by sourceCDE
Ha Yao Group Bio Gong Cheng Co., Ltd. romanizedCYHS2601367Generic2026/06/10Not stated by sourceCDE
Hubei Cheng Tian Pharma Co., Ltd. romanizedCYHS2601104Generic2026/05/13Not stated by sourceCDE
Shandong Fang Ming Pharma Group Co., Ltd. romanizedCYHS2600938Generic2026/04/23Not stated by sourceCDE
Ma Ying Long Pharma Group Co., Ltd. romanizedCYHS2600823Generic2026/04/09Not stated by sourceCDE
Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCYHS2600433Generic2026/02/10Not stated by sourceCDE
Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCYHS2600432Generic2026/02/10Not stated by sourceCDE
Haerbin Da Zhong Pharmaceutical Co., Ltd. romanizedCYHS2600431Generic2026/02/10Not stated by sourceCDE
Hubei Ke Yi Pharma Co., Ltd. romanizedCYHS2600243Generic2026/01/21Not stated by sourceCDE
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS2600180Generic2026/01/14Not stated by sourceCDE
Hunan Di Nuo Pharmaceutical Co., Ltd. romanizedCYHS2600094Generic2026/01/08Not stated by sourceCDE
API registrations

Non-component matches: 30 companies with A status and 9 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
克立硼罗 · No verified English nameShandong Da Yi Jing Cheng Pharma Co., Ltd. romanizedY20260000724IExact ingredient2026/09/02CDE
克立硼罗 · No verified English nameJiangsu Lianhuan Pharmaceutical Co.,Ltd.Y20260000008IExact ingredient2026/02/03CDE
克立硼罗 · No verified English nameShandong Bo Yuan Pharma Co., Ltd. romanizedY20250001376IExact ingredient2025/12/17CDE
克立硼罗 · No verified English nameShanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanizedY20250001097IExact ingredient2025/10/16CDE
克立硼罗 · No verified English nameShandong Fang Ming Pharma Group Co., Ltd. romanizedY20250000715IExact ingredient2025/08/14CDE
克立硼罗 · No verified English nameZhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanizedY20250000789IExact ingredient2025/08/06CDE
克立硼罗 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20250000473AExact ingredient2026/11/04CDE
克立硼罗 · No verified English nameLanzhou Dong Rui Pharmaceutical Co., Ltd. romanizedY20250000195IExact ingredient2025/03/18CDE
克立硼罗 · No verified English nameZhejiang Jiu Zhou Pharma Co., Ltd. romanizedY20240001350AExact ingredient2026/06/01CDE
克立硼罗 · No verified English nameHa Yao Group San Jing Ming Shui Pharma Co., Ltd. romanizedY20240001304IExact ingredient2024/12/12CDE
克立硼罗 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20240001257IExact ingredient2024/12/04CDE
克立硼罗 · No verified English nameJiangsu Run An Pharmaceutical Co., Ltd. romanizedY20240001060AExact ingredient2026/05/15CDE
克立硼罗 · No verified English nameChongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanizedY20240001071AExact ingredient2026/04/29CDE
克立硼罗 · No verified English nameBeijing Foyou Pharma CO.,LTDY20240000682AExact ingredient2025/10/22CDE
克立硼罗 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20240000468AExact ingredient2025/11/14CDE
克立硼罗 · No verified English nameXu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanizedY20240000561AExact ingredient2026/04/10CDE
克立硼罗 · No verified English nameBeijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedY20240000380AExact ingredient2025/09/30CDE
克立硼罗 · No verified English nameYi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanizedY20240000269AExact ingredient2025/09/15CDE
克立硼罗 · No verified English nameShanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanizedY20240000361AExact ingredient2025/12/17CDE
克立硼罗 · No verified English nameAnhui Pu Li Pharma Co., Ltd. romanizedY20240000303AExact ingredient2026/09/03CDE
克立硼罗 · No verified English nameZhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedY20230001078AExact ingredient2025/06/26CDE
克立硼罗 · No verified English nameHunan Ming Rui Pharmaceutical Co., Ltd. romanizedY20230000744AExact ingredient2026/11/11CDE
克立硼罗 · No verified English nameShandong Cheng Hui Shuang Da Pharma Co., Ltd. romanizedY20230000985AExact ingredient2026/05/20CDE
克立硼罗 · No verified English nameHubei Heng An Fu Lin Pharma Co., Ltd. romanizedY20230000967AExact ingredient2026/08/08CDE
克立硼罗 · No verified English nameZhongshan Wanhan Pharmaceuticals Co., Ltd.Y20230000954AExact ingredient2025/08/11CDE
克立硼罗 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20230000908AExact ingredient2026/05/20CDE
克立硼罗 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20230000653AExact ingredient2024/12/13CDE
克立硼罗 · No verified English nameShao Xing Min Sheng Pharmaceuticals Co., Ltd. romanizedY20230000426AExact ingredient2025/03/25CDE
克立硼罗 · No verified English nameSichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanizedY20230000644AExact ingredient2025/06/03CDE
克立硼罗 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20230000380AExact ingredient2025/03/19CDE
克立硼罗 · No verified English nameJiangxi Ke Rui Pharma Co., Ltd. romanizedY20230000260AExact ingredient2025/08/01CDE
克立硼罗 · No verified English nameQilu Pharmaceutical Co., Ltd.Y20230000191AExact ingredient2024/10/25CDE
克立硼罗 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20220001301AExact ingredient2024/08/15CDE
克立硼罗 · No verified English nameShanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanizedY20220001304AExact ingredient2025/06/26CDE
克立硼罗 · No verified English nameJiangxi Tong He Pharma Co., Ltd. romanizedY20220001177AExact ingredient2026/11/10CDE
克立硼罗 · No verified English nameZhang Zhi Shi Yuan Yan Pharmaceuticals Technology Co., Ltd. romanizedY20220001261AExact ingredient2026/07/11CDE
克立硼罗 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20220001073AExact ingredient2026/06/16CDE
克立硼罗 · No verified English nameNanjing Hai Na Pharmaceutical Co., Ltd. romanizedY20220000559AExact ingredient2024/02/08CDE
克立硼罗 · No verified English nameHonour Lab Limited, Unit - III romanizedY20210000553AExact ingredient2025/07/29CDE

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.

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. 2026/11/13No longer listed under review

    Guangdong Ke Hong Pharma Co., Ltd. romanized

    CYHB2601958

    Fact date: 2026/11/13 · Site observation date: 2026/11/13

    Accepted: 2026/10/26

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/11No longer listed under review

    Chongqing Huapont Pharmaceutical Co., Ltd.

    CYHS2502124

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

    Accepted: 2025/06/14

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/11/03No longer listed under review

    Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized

    CYHS2501906

    Fact date: 2026/11/03 · Site observation date: 2026/11/03

    Accepted: 2025/05/28

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  4. 2026/10/29Accepted

    Qilu Pharmaceutical Co., Ltd.

    CYHB2601976

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  5. 2026/10/29Accepted

    Qilu Pharmaceutical Co., Ltd.

    CYHB2601975

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  6. 2026/10/26Accepted

    Guangdong Ke Hong Pharma Co., Ltd. romanized

    CYHB2601958

    Fact date: 2026/10/26 · Site observation date: 2026/10/27

    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.

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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