Monthly
US$200
Billed every month
Sign in to subscribeAs of 13 November 2026, for Tacrolimus Sustained-release Capsules, 6 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 9 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as ASTAGRAF XL (NDA 204096, ASTELLAS PHARMA US INC).
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
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 4 of 4 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 Capsules. 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.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| ASTAGRAF XL | ASTELLAS PHARMA US INC | NDA 204096 · Product no. 001, 002, 003 | CAPSULE, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 2013/07/19 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| PROGRAF | ASTELLAS PHARMA US INC | NDA 050708 · Product no. 001, 002 | CAPSULE | ORAL | HUMAN PRESCRIPTION DRUG | 1994/04/08 |
| PROGRAF | ASTELLAS PHARMA US INC | NDA 050709 · Product no. 001 | INJECTABLE | INJECTION | HUMAN PRESCRIPTION DRUG | 1994/04/08 |
| PROGRAF | ASTELLAS PHARMA US INC | NDA 050708 · Product no. 003 | CAPSULE | ORAL | HUMAN PRESCRIPTION DRUG | 1998/08/24 |
| PROTOPIC | LEO PHARMA AS | NDA 050777 · Product no. 001, 002 | OINTMENT | TOPICAL | HUMAN PRESCRIPTION DRUG | 2000/12/08 |
| ENVARSUS XR | VELOXIS PHARMACEUTICALS INC | NDA 206406 · Product no. 001, 002, 003 | TABLET, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 2015/07/10 |
| PROGRAF | ASTELLAS PHARMA US INC | NDA 210115 · Product no. 001, 002 | FOR SUSPENSION | ORAL | HUMAN PRESCRIPTION DRUG | 2018/05/24 |
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.
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.
Loaded records: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264058 | 2026/04/21 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20264057 | 2026/04/21 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20269058 | 2026/03/19 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20255647 | 2025/09/30 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20255646 | 2025/09/30 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20254680 | 2025/06/30 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253557 | 2025/03/04 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253556 | 2025/03/04 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20253242 | 2025/01/24 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20253241 | 2025/01/24 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20253165 | 2025/01/14 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20253166 | 2025/01/14 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 国药准字H20244137 | 2024/06/25 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 国药准字H20244136 | 2024/06/25 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Jiang Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20243200 | 2024/02/23 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223424 | 2022/06/28 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223422 | 2022/06/28 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223423 | 2022/06/28 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
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.
Loaded records: 22 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | 国药准字J20150055 | 0.5mg | Category B | XL04ADT002E003010101076 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20255646 | 1mg | Category B | XL04ADT002E003010102777 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20253241 | 0.5mg | Category B | XL04ADT002E003010104127 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20244136 | 0.5mg | Category B | XL04ADT002E003010104520 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20253165 | 1mg | Category B | XL04ADT002E003010104948 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253557 | 0.5mg | Category B | XL04ADT002E003010105815 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223424 | 0.5mg | Category B | XL04ADT002E003010180435 | NHSA |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264057 | 1mg | Category B | XL04ADT002E003010182990 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20243200 | 5mg | Category B | XL04ADT002E003010183516 | NHSA |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20254680 | 1mg | Category B | XL04ADT002E003010183879 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20253241 | 0.5mg | Category B | XL04ADT002E003010204127 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253557 | 0.5mg | Category B | XL04ADT002E003010205815 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字HJ20150029 | 0.5mg | Category B | XL04ADT002E003010279406 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字J20150056 | 1mg | Category B | XL04ADT002E003020101076 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20255647 | 0.5mg | Category B | XL04ADT002E003020102777 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20253242 | 1mg | Category B | XL04ADT002E003020104127 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20244137 | 1mg | Category B | XL04ADT002E003020104520 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20253166 | 0.5mg | Category B | XL04ADT002E003020104948 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253556 | 1mg | Category B | XL04ADT002E003020105815 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223423 | 1mg | Category B | XL04ADT002E003020180435 | NHSA |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264058 | 0.5mg | Category B | XL04ADT002E003020182990 | NHSA |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20269058 | 0.5mg | Category B | XL04ADT002E003020183879 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20253242 | 1mg | Category B | XL04ADT002E003020204127 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20253556 | 1mg | Category B | XL04ADT002E003020205815 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字HJ20150031 | 1mg | Category B | XL04ADT002E003020279406 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223422 | 5mg | Category B | XL04ADT002E003030180435 | NHSA |
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.
Loaded records: 6 filings and 3 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602572 | Generic | 2026/10/19 | Not stated by source | CDE |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602571 | Generic | 2026/10/19 | Not stated by source | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601292 | Generic | 2026/06/04 | Not stated by source | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601291 | Generic | 2026/06/04 | Not stated by source | CDE |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600740 | Generic | 2026/03/27 | Not stated by source | CDE |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600739 | Generic | 2026/03/27 | Not stated by source | CDE |
Loaded records: 6 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602572 | Generic | 2026/10/19 | Not stated by source | CDE |
| Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | CYHS2602571 | Generic | 2026/10/19 | Not stated by source | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601292 | Generic | 2026/06/04 | Not stated by source | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2601291 | Generic | 2026/06/04 | Not stated by source | CDE |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600740 | Generic | 2026/03/27 | Not stated by source | CDE |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2600739 | Generic | 2026/03/27 | Not stated by source | CDE |
Non-component matches: 12 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 他克莫司 · No verified English name | Zhejiang Hai Xiang Pharma Co., Ltd. romanized | Y20250000882 | I | Exact ingredient | 2025/09/02 | CDE |
| 他克莫司 · No verified English name | Bills Biotech Pvt. Ltd. | Y20240000691 | I | Exact ingredient | 2024/10/10 | CDE |
| 他克莫司 · No verified English name | Sichuan Nuo Yi Sheng Pharma Co., Ltd. romanized | Y20240000730 | A | Exact ingredient | 2025/12/17 | CDE |
| 他克莫司 · No verified English name | Name not romanized | Y20240000073 | I | Exact ingredient | 2024/07/16 | CDE |
| 他克莫司 · No verified English name | Biocon Biosphere Limited | Y20240000135 | A | Exact ingredient | 2026/06/01 | CDE |
| 他克莫司 · No verified English name | Lu Nan Xin Shi Dai Bio Technology Co., Ltd. romanized | Y20230001120 | A | Exact ingredient | 2026/05/20 | CDE |
| 他克莫司 · No verified English name | Biocon Limited | Y20220000745 | A | Exact ingredient | 2024/12/13 | CDE |
| 他克莫司 · No verified English name | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20210000983 | A | Exact ingredient | 2024/04/13 | CDE |
| 他克莫司 · No verified English name | CERES F&D Incorporated | Y20210000344 | I | Exact ingredient | 2021/07/12 | CDE |
| 他克莫司 · No verified English name | Concord Biotech Limited | Y20210000143 | I | Exact ingredient | 2025/12/30 | CDE |
| 他克莫司 · No verified English name | Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | Y20210000274 | A | Exact ingredient | 2026/06/13 | CDE |
| 他克莫司 · No verified English name | Astellas Pharma Inc. | Y20190000843 | I | Exact ingredient | 2020/03/09 | CDE |
| 他克莫司 · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20190009352 | A | Exact ingredient | — | CDE |
| 他克莫司 · No verified English name | Fujian Ke Rui Pharma Co., Ltd. romanized | Y20190008905 | A | Exact ingredient | 2025/03/06 | CDE |
| 他克莫司 · No verified English name | Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20190006989 | A | Exact ingredient | 2026/06/29 | CDE |
| 他克莫司 · No verified English name | Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20190006104 | A | Exact ingredient | 2025/08/08 | CDE |
| 他克莫司 · No verified English name | Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20190006081 | A | Exact ingredient | 2025/07/18 | CDE |
| 他克莫司 · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20170001979 | A | Exact ingredient | 2023/03/24 | CDE |
| 他克莫司 · No verified English name | TAPI Czech Industries s.r.o. | Y20170000349 | A | Exact ingredient | 2025/05/08 | CDE |
| 他克莫司 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20170000052 | I | Exact ingredient | — | CDE |
| 他克莫司 · No verified English name | Biocon Limited | Y20170000011 | I | Exact ingredient | — | CDE |
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.
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.
CYHS2602572
Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗CYHS2602571
Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
Sign in to subscribeUS$540
Billed every three months
US$180 per month
Sign in to subscribeUS$1,920
Billed every year
US$160 per month
Sign in to subscribeSeparate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy