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Sign in to subscribeLanthanum Carbonate Chewable Tablets
As of 13 November 2026, for Lanthanum Carbonate Chewable Tablets, 2 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 14 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as FOSRENOL (NDA 021468, TAKEDA PHARMACEUTICALS USA INC).
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
Current coverage may be incomplete
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: Chewable 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 name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| FOSRENOL | TAKEDA PHARMACEUTICALS USA INC | NDA 021468 · Product no. 002 | TABLET, CHEWABLE | ORAL | HUMAN PRESCRIPTION DRUG | 2004/10/26 |
| FOSRENOL | TAKEDA PHARMACEUTICALS USA INC | NDA 021468 · Product no. 003, 004 | TABLET, CHEWABLE | ORAL | HUMAN PRESCRIPTION DRUG | 2005/11/23 |
| FOSRENOL | TAKEDA PHARMACEUTICALS USA INC | NDA 021468 · Product no. 001 | TABLET, CHEWABLE | ORAL | DISCONTINUED | 2004/10/26 |
Other dosage forms of the same ingredient
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| FOSRENOL | TAKEDA PHARMACEUTICALS USA INC | NDA 204734 · Product no. 001, 002 | POWDER | ORAL | HUMAN PRESCRIPTION DRUG | 2014/09/24 |
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.
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.
Catalogue holders14View records ↓
Under-review filings2View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers15View records ↓
API companies with A status20View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 11 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 |
|---|---|---|---|---|---|---|
| Zhejiang Zhong Tong Pharma Co., Ltd. romanized | Zhejiang Zhong Tong Pharma Co., Ltd. romanized | 国药准字H20263491 | 2026/03/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized | Suzhou Ai Mei Jin Pharmaceutical Co., Ltd. romanized | 国药准字H20253619 | 2025/03/11 | See source | Not stated by source | CDE |
| Natco Pharma Limited | Natco Pharma Limited | 国药准字HJ20240159 | 2024/12/06 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Natco Pharma Limited | Natco Pharma Limited | 国药准字HJ20240160 | 2024/12/06 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244877 | 2024/09/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20244505 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20244466 | 2024/07/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20243904 | 2024/06/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ren He Yi Kang Group Co., Ltd. romanized | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20243738 | 2024/05/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ren He Yi Kang Group Co., Ltd. romanized | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20243739 | 2024/05/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20230116 | 2023/10/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H20233126 | 2023/02/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H20233125 | 2023/02/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20223690 | 2022/09/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20203039 | 2022/03/15 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Zi Hao Shi Dai Pharma Co., Ltd. romanized | Sichuan Zi Hao Shi Dai Pharma Co., Ltd. romanized | 国药准字H20213953 | 2021/12/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shire Pharmaceuticals Ireland Limited | Hamol Limited | H20171351;H20171352 | 2012/02/10 | 500mg | Imported originator drug | 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.
NHSA drug codes
Loaded records: 15 distinct approval numbers and 14 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20233126 | See source | Category B | XV03AET152A005010101287 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20223690 | See source | Category B | XV03AET152A005010101606 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244877 | See source | Category B | XV03AET152A005010104023 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20244466 | See source | Category B | XV03AET152A005010104145 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20244505 | See source | Category B | XV03AET152A005010104586 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20203039 | See source | Category B | XV03AET152A005010105001 | NHSA |
| HAMOL LIMITED | H20171351 | 500mg | Category B | XV03AET152A005010179538 | NHSA |
| Qing Shen Hong Hao Pharmaceutical Co., Ltd. romanized | 国药准字H20213953 | See source | Category B | XV03AET152A005010181555 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243738 | See source | Category B | XV03AET152A005010183033 | NHSA |
| Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253619 | See source | Category B | XV03AET152A005010183777 | NHSA |
| Natco Pharma Limited | 国药准字HJ20240159 | See source | Category B | XV03AET152A005010184131 | NHSA |
| Zhejiang Zhong Tong Pharma Co., Ltd. romanized | 国药准字H20263491 | See source | Category B | XV03AET152A005010184243 | NHSA |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20233126 | See source | Category B | XV03AET152A005010201287 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20223690 | See source | Category B | XV03AET152A005010201606 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20244505 | See source | Category B | XV03AET152A005010204586 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20203039 | See source | Category B | XV03AET152A005010205001 | NHSA |
| Takeda Pharmaceuticals International AG Ireland Branch | 国药准字HJ20171351 | See source | Category B | XV03AET152A005010279538 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243738 | See source | Category B | XV03AET152A005010283033 | NHSA |
| Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253619 | See source | Category B | XV03AET152A005010283777 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20223690 | See source | Category B | XV03AET152A005010301606 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20244505 | See source | Category B | XV03AET152A005010304586 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20203039 | See source | Category B | XV03AET152A005010305001 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243738 | See source | Category B | XV03AET152A005010383033 | NHSA |
| Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253619 | See source | Category B | XV03AET152A005010383777 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243738 | See source | Category B | XV03AET152A005010483033 | NHSA |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H20233125 | See source | Category B | XV03AET152A005020101287 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243739 | See source | Category B | XV03AET152A005020183033 | NHSA |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H20233125 | See source | Category B | XV03AET152A005020201287 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243739 | See source | Category B | XV03AET152A005020283033 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243739 | See source | Category B | XV03AET152A005020383033 | 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.
Current under-review applications
Loaded records: 2 filings and 2 distinct first applicants.
Generic 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2600761 | Generic | 2026/04/01 | Not stated by source | CDE |
| Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized | CYHS2600492 | Generic | 2026/02/14 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2600761 | Generic | 2026/04/01 | Not stated by source | CDE |
| Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized | CYHS2600492 | Generic | 2026/02/14 | Not stated by source | CDE |
API registrations
Non-component matches: 20 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 碳酸镧 · No verified English name | Shandong Ke Xin Pharma Co., Ltd. romanized | Y20260000124 | I | Exact ingredient | 2026/02/13 | CDE |
| 碳酸镧 · No verified English name | Ri Zhao Zheng Ji Pharma Co., Ltd. romanized | Y20250000998 | I | Exact ingredient | 2025/10/16 | CDE |
| 碳酸镧 · No verified English name | Nei Menggu Jing Dong Pharma Co., Ltd. romanized | Y20250000378 | A | Exact ingredient | 2026/10/12 | CDE |
| 碳酸镧 · No verified English name | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20240001423 | A | Exact ingredient | 2026/07/20 | CDE |
| 碳酸镧 · No verified English name | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | Y20240000789 | A | Exact ingredient | 2025/12/08 | CDE |
| 碳酸镧 · No verified English name | Zhejiang Qian Yuan Hai Li Sheng Pharmaceutical Co., Ltd. romanized | Y20240000582 | A | Exact ingredient | 2026/01/30 | CDE |
| 碳酸镧 · No verified English name | Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized | Y20240000103 | A | Exact ingredient | 2025/11/25 | CDE |
| 碳酸镧 · No verified English name | Hebei Hua Chen Pharma Group Co., Ltd. romanized | Y20240000166 | A | Exact ingredient | 2025/08/14 | CDE |
| 碳酸镧 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20230001019 | A | Exact ingredient | 2026/06/02 | CDE |
| 碳酸镧 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20220001199 | A | Exact ingredient | 2026/07/09 | CDE |
| 碳酸镧 · No verified English name | Suzhou Zheng Ji Pharma Co., Ltd. romanized | Y20220000535 | A | Exact ingredient | 2025/03/18 | CDE |
| 碳酸镧 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20220000985 | A | Exact ingredient | 2025/04/29 | CDE |
| 碳酸镧 · No verified English name | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Y20220001024 | A | Exact ingredient | 2024/06/28 | CDE |
| 碳酸镧 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20220000933 | A | Exact ingredient | 2026/01/17 | CDE |
| 碳酸镧 · No verified English name | Shenyang Fu Ning Pharma Co., Ltd. romanized | Y20210001310 | A | Exact ingredient | 2024/01/17 | CDE |
| 碳酸镧 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20220000402 | A | Exact ingredient | 2024/11/09 | CDE |
| 碳酸镧 · No verified English name | Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20220000312 | A | Exact ingredient | 2025/07/29 | CDE |
| 碳酸镧 · No verified English name | SYMED LABS LIMITED | Y20220000271 | I | Exact ingredient | 2024/09/27 | CDE |
| 碳酸镧 · No verified English name | Matrix Pharmacorp Private Limited | Y20220000002 | A | Exact ingredient | 2026/03/05 | CDE |
| 碳酸镧 · No verified English name | Sichuan Zi Hao Shi Dai Pharma Co., Ltd. romanized | Y20200001552 | A | Exact ingredient | 2026/07/27 | CDE |
| 碳酸镧 · No verified English name | Jiangsu Pu Run Biopharmaceuticals Co., Ltd. romanized | Y20200001500 | A | Exact ingredient | 2024/11/19 | CDE |
| 碳酸镧 · No verified English name | Natco Pharma Limited | Y20200001143 | A | Exact ingredient | 2025/12/25 | CDE |
| 碳酸镧 · No verified English name | Solara Active Pharma Sciences Limited | Y20200000776 | I | Exact ingredient | 2022/10/14 | CDE |
| 碳酸镧 · No verified English name | Chengdu Xin Yue Pharmaceuticals Co., Ltd. romanized | Y20180001526 | I | Exact ingredient | 2019/02/15 | CDE |
| 碳酸镧 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20170000984 | A | Exact ingredient | 2024/03/23 | 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.
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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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