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Erythromycin Lactobionate for Injection

As 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

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: 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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

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.

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: 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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Guangdong Yue He Ze Drug Research Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202657082026/08/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanizedHainan Ling Kang Pharmaceutical Co., Ltd. romanized国药准字H202655772026/08/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanizedHainan Ling Kang Pharmaceutical Co., Ltd. romanized国药准字H202655782026/08/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanizedGuangdong Long Fu Pharma Co., Ltd. romanized国药准字H202631492026/01/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H430200282026/10/16See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202692532026/10/16See sourceDrug that passed quality-and-efficacy consistency evaluationCDE

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: 30 distinct approval numbers and 18 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H31021503See sourceCategory AXJ01FAH016B001010100792NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H21021678See sourceCategory AXJ01FAH016B001010101122NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020871See sourceCategory AXJ01FAH016B001010101949NHSA
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H51023236See sourceCategory AXJ01FAH016B001010102080NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See sourceCategory AXJ01FAH016B001010102503NHSA
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H14020379See sourceCategory AXJ01FAH016B001010102946NHSA
Shanxi Shuang Yan Pharma Co., Ltd. romanized国药准字H14020729See sourceCategory AXJ01FAH016B001010102954NHSA
Ha Yao Group Pharmaceutical Factory romanized国药准字H23021442See sourceCategory AXJ01FAH016B001010103712NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020028See sourceCategory AXJ01FAH016B001010105006NHSA
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H45021339See sourceCategory AXJ01FAH016B001010105156NHSA
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021156See sourceCategory AXJ01FAH016B001010105283NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265578See sourceCategory AXJ01FAH016B001010181251NHSA
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized国药准字H20263854See sourceCategory AXJ01FAH016B001010181979NHSA
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized国药准字H20263149See sourceCategory AXJ01FAH016B001010185190NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020871See sourceCategory AXJ01FAH016B001010201949NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See sourceCategory AXJ01FAH016B001010202503NHSA
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H14020379See sourceCategory AXJ01FAH016B001010202946NHSA
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023638See sourceCategory AXJ01FAH016B001010204383NHSA
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021156See sourceCategory AXJ01FAH016B001010205283NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265578See sourceCategory AXJ01FAH016B001010281251NHSA
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized国药准字H20263149See sourceCategory AXJ01FAH016B001010285190NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See sourceCategory AXJ01FAH016B001010302503NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H21021679See sourceCategory AXJ01FAH016B001020101122NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020872See sourceCategory AXJ01FAH016B001020101949NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See sourceCategory AXJ01FAH016B001020102503NHSA
Shanxi Shuang Yan Pharma Co., Ltd. romanized国药准字H14022626See sourceCategory AXJ01FAH016B001020102954NHSA
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023637See sourceCategory AXJ01FAH016B001020104383NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020027See sourceCategory AXJ01FAH016B001020105006NHSA
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H45021338See sourceCategory AXJ01FAH016B001020105156NHSA
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021155See sourceCategory AXJ01FAH016B001020105283NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265577See sourceCategory AXJ01FAH016B001020181251NHSA
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized国药准字H20263855See sourceCategory AXJ01FAH016B001020181979NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020872See sourceCategory AXJ01FAH016B001020201949NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020027See sourceCategory AXJ01FAH016B001020205006NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265577See sourceCategory AXJ01FAH016B001020281251NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H21021678See sourceCategory AXJ01FAH016B001030101122NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See sourceCategory AXJ01FAH016B001030102503NHSA
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023638See sourceCategory AXJ01FAH016B001030104383NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020028See sourceCategory AXJ01FAH016B001030105006NHSA
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021155See sourceCategory AXJ01FAH016B001030105283NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See sourceCategory AXJ01FAH016B001030202503NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H21021679See sourceCategory AXJ01FAH016B001040101122NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See sourceCategory AXJ01FAH016B001040102503NHSA
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See sourceCategory AXJ01FAH016B001050102503NHSA
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H51023235See sourceCategory AXJ01FAH016B003010102080NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See sourceCategory AXJ01FAH016B013010104152NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See sourceCategory AXJ01FAH016B013010204152NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See sourceCategory AXJ01FAH016B013020104152NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See sourceCategory AXJ01FAH016B013020204152NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See sourceCategory AXJ01FAH016B013030104152NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See sourceCategory AXJ01FAH016B013040104152NHSA
Xian Di Sai Bio Pharma Co., Ltd. romanized国药准字H61021775See sourceCategory AXJ01FAH016B014010102470NHSA
Guangdong Yue He Ze Drug Research Co., Ltd. romanized国药准字H20265708See sourceCategory AXJ01FAH016B001010184887NHSA

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: 13 filings and 8 distinct first applicants.

Generic 11 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Suzhou Erye Pharmaceutical Co., LtdCYHS2504472Generic2025/12/30Not stated by sourceCDE
Suzhou Erye Pharmaceutical Co., LtdCYHS2504471Generic2025/12/30Not stated by sourceCDE
Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS2601857Generic2026/08/03Not stated by sourceCDE
Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCYHS2502490Generic2025/07/12Not stated by sourceCDE
Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCYHS2502489Generic2025/07/12Not stated by sourceCDE
Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanizedCYHS2500734Generic2025/02/13Not stated by sourceCDE
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanizedCYHB2650137Supplement2026/06/16Not stated by sourceCDE
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanizedCYHB2650136Supplement2026/06/16Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2600795Generic2026/04/08Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2600794Generic2026/04/08Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2503278Generic2025/09/05Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2503277Generic2025/09/05Not stated by sourceCDE
Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Haikou Qi Li Pharmaceutical Co., Ltd. romanizedCYHS2502675Generic2025/07/24Not 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
Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS2601857Generic2026/08/03Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2600795Generic2026/04/08Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2600794Generic2026/04/08Not stated by sourceCDE
API registrations

Non-component matches: 4 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
乳糖酸红霉素 · No verified English nameChengdu Bai Yu Pharmaceutical Co., Ltd. romanizedY20260000044IExact ingredient2026/01/30CDE
乳糖酸红霉素 · No verified English nameJiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanizedY20250001359IExact ingredient2025/12/25CDE
乳糖酸红霉素 · No verified English nameZhejiang Hua Na Pharma Co., Ltd. romanizedY20250000445IExact ingredient2025/06/06CDE
乳糖酸红霉素 · No verified English nameGuangdong Tai Sen De Pharmaceutical Co., Ltd. romanizedY20240001069IExact ingredient2024/12/02CDE
乳糖酸红霉素 · No verified English nameBeijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedY20230001264AExact ingredient2025/10/23CDE
乳糖酸红霉素 · No verified English nameXian Li Jun Pharmaceutical Co., Ltd. romanizedY20190005670AExact ingredient2026/01/07CDE
乳糖酸红霉素 · No verified English nameHuang Shi Huang Kang Pharma Co., Ltd. romanizedY20190004886AExact ingredient—CDE
乳糖酸红霉素 · No verified English nameMei Luo Pharma Co., Ltd. romanizedY20190004202AExact ingredient2025/01/16CDE

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. 2026/11/07No longer listed under review

    Guangdong Tai Sen De Pharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.

    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 ↗
  2. 2026/11/07No longer listed under review

    Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized

    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 ↗
  3. 2026/10/16Supplement delivery

    Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

    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 ↗
  4. 2026/10/16Supplement delivery

    Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

    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 ↗

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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