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Sign in to subscribeAs of 13 November 2026, for Erythromycin Lactobionate for Injection, 13 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as ERYTHROCIN (NDA 050609, HOSPIRA INC).
Last 90 days: No longer listed under review: 2 applicationsSupplement delivery: 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 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: for Injection. 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 |
|---|---|---|---|---|---|---|
| ERYTHROCIN | HOSPIRA INC | NDA 050609 · Product no. 001 | INJECTABLE | INJECTION | HUMAN PRESCRIPTION DRUG | 1986/09/24 |
| ERYTHROCIN | HOSPIRA INC | NDA 050182 · Product no. 002, 003 | INJECTABLE | INJECTION | DISCONTINUED | Approved prior to 1982 (exact date not listed) |
| ERYTHROCIN | HOSPIRA INC | NDA 050609 · Product no. 002 | INJECTABLE | INJECTION | DISCONTINUED | 1986/09/24 |
No listings in this group among the displayed brand names.
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: 4 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| Guangdong Yue He Ze Drug Research Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20265708 | 2026/08/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20265577 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20265578 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized | Guangdong Long Fu Pharma Co., Ltd. romanized | 国药准字H20263149 | 2026/01/20 | See source | 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H43020028 | 2026/10/16 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20269253 | 2026/10/16 | See source | Drug that passed quality-and-efficacy consistency evaluation | 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: 30 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | 国药准字H31021503 | See source | Category A | XJ01FAH016B001010100792 | NHSA |
| Mei Luo Pharma Co., Ltd. romanized | 国药准字H21021678 | See source | Category A | XJ01FAH016B001010101122 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020871 | See source | Category A | XJ01FAH016B001010101949 | NHSA |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H51023236 | See source | Category A | XJ01FAH016B001010102080 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022363 | See source | Category A | XJ01FAH016B001010102503 | NHSA |
| Hubei Mei Lin Pharma Co., Ltd. romanized | 国药准字H14020379 | See source | Category A | XJ01FAH016B001010102946 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H14020729 | See source | Category A | XJ01FAH016B001010102954 | NHSA |
| Ha Yao Group Pharmaceutical Factory romanized | 国药准字H23021442 | See source | Category A | XJ01FAH016B001010103712 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H43020028 | See source | Category A | XJ01FAH016B001010105006 | NHSA |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H45021339 | See source | Category A | XJ01FAH016B001010105156 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H36021156 | See source | Category A | XJ01FAH016B001010105283 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265578 | See source | Category A | XJ01FAH016B001010181251 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20263854 | See source | Category A | XJ01FAH016B001010181979 | NHSA |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20263149 | See source | Category A | XJ01FAH016B001010185190 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020871 | See source | Category A | XJ01FAH016B001010201949 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022363 | See source | Category A | XJ01FAH016B001010202503 | NHSA |
| Hubei Mei Lin Pharma Co., Ltd. romanized | 国药准字H14020379 | See source | Category A | XJ01FAH016B001010202946 | NHSA |
| Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 国药准字H34023638 | See source | Category A | XJ01FAH016B001010204383 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H36021156 | See source | Category A | XJ01FAH016B001010205283 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265578 | See source | Category A | XJ01FAH016B001010281251 | NHSA |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20263149 | See source | Category A | XJ01FAH016B001010285190 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022363 | See source | Category A | XJ01FAH016B001010302503 | NHSA |
| Mei Luo Pharma Co., Ltd. romanized | 国药准字H21021679 | See source | Category A | XJ01FAH016B001020101122 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020872 | See source | Category A | XJ01FAH016B001020101949 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022364 | See source | Category A | XJ01FAH016B001020102503 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H14022626 | See source | Category A | XJ01FAH016B001020102954 | NHSA |
| Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 国药准字H34023637 | See source | Category A | XJ01FAH016B001020104383 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H43020027 | See source | Category A | XJ01FAH016B001020105006 | NHSA |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H45021338 | See source | Category A | XJ01FAH016B001020105156 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H36021155 | See source | Category A | XJ01FAH016B001020105283 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265577 | See source | Category A | XJ01FAH016B001020181251 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20263855 | See source | Category A | XJ01FAH016B001020181979 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020872 | See source | Category A | XJ01FAH016B001020201949 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H43020027 | See source | Category A | XJ01FAH016B001020205006 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265577 | See source | Category A | XJ01FAH016B001020281251 | NHSA |
| Mei Luo Pharma Co., Ltd. romanized | 国药准字H21021678 | See source | Category A | XJ01FAH016B001030101122 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022364 | See source | Category A | XJ01FAH016B001030102503 | NHSA |
| Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 国药准字H34023638 | See source | Category A | XJ01FAH016B001030104383 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H43020028 | See source | Category A | XJ01FAH016B001030105006 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H36021155 | See source | Category A | XJ01FAH016B001030105283 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022364 | See source | Category A | XJ01FAH016B001030202503 | NHSA |
| Mei Luo Pharma Co., Ltd. romanized | 国药准字H21021679 | See source | Category A | XJ01FAH016B001040101122 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022364 | See source | Category A | XJ01FAH016B001040102503 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H61022363 | See source | Category A | XJ01FAH016B001050102503 | NHSA |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H51023235 | See source | Category A | XJ01FAH016B003010102080 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053846 | See source | Category A | XJ01FAH016B013010104152 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053846 | See source | Category A | XJ01FAH016B013010204152 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053847 | See source | Category A | XJ01FAH016B013020104152 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053847 | See source | Category A | XJ01FAH016B013020204152 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053846 | See source | Category A | XJ01FAH016B013030104152 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20053847 | See source | Category A | XJ01FAH016B013040104152 | NHSA |
| Xian Di Sai Bio Pharma Co., Ltd. romanized | 国药准字H61021775 | See source | Category A | XJ01FAH016B014010102470 | NHSA |
| Guangdong Yue He Ze Drug Research Co., Ltd. romanized | 国药准字H20265708 | See source | Category A | XJ01FAH016B001010184887 | 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: 13 filings and 8 distinct first applicants.
Generic 11 · Supplement 2
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2601857 | Generic | 2026/08/03 | Not stated by source | CDE |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | CYHS2600795 | Generic | 2026/04/08 | Not stated by source | CDE |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | CYHS2600794 | Generic | 2026/04/08 | Not stated by source | CDE |
Non-component matches: 4 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 乳糖酸红霉素 · No verified English name | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | Y20260000044 | I | Exact ingredient | 2026/01/30 | CDE |
| 乳糖酸红霉素 · No verified English name | Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | Y20250001359 | I | Exact ingredient | 2025/12/25 | CDE |
| 乳糖酸红霉素 · No verified English name | Zhejiang Hua Na Pharma Co., Ltd. romanized | Y20250000445 | I | Exact ingredient | 2025/06/06 | CDE |
| 乳糖酸红霉素 · No verified English name | Guangdong Tai Sen De Pharmaceutical Co., Ltd. romanized | Y20240001069 | I | Exact ingredient | 2024/12/02 | CDE |
| 乳糖酸红霉素 · No verified English name | Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Y20230001264 | A | Exact ingredient | 2025/10/23 | CDE |
| 乳糖酸红霉素 · No verified English name | Xian Li Jun Pharmaceutical Co., Ltd. romanized | Y20190005670 | A | Exact ingredient | 2026/01/07 | CDE |
| 乳糖酸红霉素 · No verified English name | Huang Shi Huang Kang Pharma Co., Ltd. romanized | Y20190004886 | A | Exact ingredient | — | CDE |
| 乳糖酸红霉素 · No verified English name | Mei Luo Pharma Co., Ltd. romanized | Y20190004202 | A | Exact ingredient | 2025/01/16 | 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.
CYHS2404422
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2024/12/20
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2404313
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2024/12/12
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHB2550288 · 国药准字H20269253
Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 3 ↗CYHB2550287
Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 2 ↗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.
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