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Propranolol hydrochloride oral solution

As of 13 November 2026, for Propranolol hydrochloride oral solution, 4 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as HEMANGEOL (NDA 205410, ETON PHARMACEUTICALS INC).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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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 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: oral solution. 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
HEMANGEOL ETON PHARMACEUTICALS INC NDA 205410 · Product no. 001 SOLUTION ORAL HUMAN PRESCRIPTION DRUG 2014/03/14

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
INDERAL LA ANI PHARMACEUTICALS INC NDA 018553 · Product no. 001, 002, 003 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 1983/04/19
INDERAL LA ANI PHARMACEUTICALS INC NDA 018553 · Product no. 004 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 1987/03/18
INNOPRAN XL ANI PHARMACEUTICALS INC NDA 021438 · Product no. 001, 002 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2003/03/12
INDERAL WYETH PHARMACEUTICALS LLC NDA 016418 · Product no. 001, 002, 003, 004 TABLET ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)
INDERAL WYETH PHARMACEUTICALS LLC NDA 016418 · Product no. 009, 010 TABLET ORAL DISCONTINUED 1982/10/18
INDERAL WYETH AYERST LABORATORIES NDA 019536 · Product no. 001 SUSPENSION ORAL DISCONTINUED 1986/12/12

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: 0 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
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 2 distinct approval numbers and 2 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized国药准字H20213648See sourceNot stated by sourceXC07AAP101X001010102281NHSA
Wuhan Ke Fu Xin Yao Co., Ltd. romanized国药准字H20213549See sourceNot stated by sourceXC07AAP101X001010103014NHSA
Wuhan Ke Fu Xin Yao Co., Ltd. romanized国药准字H20213549See sourceNot stated by sourceXC07AAP101X001020103014NHSA

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: 4 filings and 4 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS2601449Generic2026/06/18Not stated by sourceCDE
Shenyang Tian Bang Pharma Co., Ltd. romanizedCYHS2602552Generic2026/10/16Not stated by sourceCDE
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS2602538Generic2026/10/14Not stated by sourceCDE
Hubei Min Kang Pharmaceutical Co., Ltd. romanizedCYHS2501650Generic2025/05/08Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS2601449Generic2026/06/18Not stated by sourceCDE
Shenyang Tian Bang Pharma Co., Ltd. romanizedCYHS2602552Generic2026/10/16Not stated by sourceCDE
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS2602538Generic2026/10/14Not stated by sourceCDE
Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanizedCYHS2601427Generic2026/06/16Not stated by sourceCDE
API registrations

Non-component matches: 14 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸普萘洛尔 · No verified English nameCSPC OUYI PHARMACEUTICAL CO., LTD.Y20250000617IExact ingredient2025/07/03CDE
盐酸普萘洛尔 · No verified English nameShou Guang Fu Kang Pharmaceutical Co., Ltd. romanizedY20250000094AExact ingredient2026/07/13CDE
盐酸普萘洛尔 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20240001144AExact ingredient2026/02/13CDE
盐酸普萘洛尔 · No verified English nameCOSMA S.P.A.Y20240000677AExact ingredient2026/09/10CDE
盐酸普萘洛尔 · No verified English nameTIANJIN LISHENG PHARMACEUTICAL CO., LTDY20230000153AExact ingredient2026/01/07CDE
盐酸普萘洛尔 · No verified English nameSAI SUPREME CHEMICALSY20220000986IExact ingredient2022/11/14CDE
盐酸普萘洛尔 · No verified English nameNei Menggu Kang Pu Pharma Co., Ltd. romanizedY20220000804AExact ingredient2024/04/09CDE
盐酸普萘洛尔 · No verified English nameYun Peng Pharmaceuticals Group Co., Ltd. romanizedY20210001242AExact ingredient2026/08/28CDE
盐酸普萘洛尔 · No verified English nameChangzhou Shi Tian Hua Pharmaceutical Co., Ltd. romanizedY20190009782AExact ingredient—CDE
盐酸普萘洛尔 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20190009686AExact ingredient2025/05/30CDE
盐酸普萘洛尔 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20190009622AExact ingredient2025/07/28CDE
盐酸普萘洛尔 · No verified English nameJiangsu Yun Yang Group Pharma Co., Ltd. romanizedY20190004980AExact ingredient2025/08/23CDE
盐酸普萘洛尔 · No verified English nameChangzhou Shi Tian Hua Pharmaceutical Co., Ltd. romanizedY20190000448IExact ingredient2019/06/28CDE
盐酸普萘洛尔 · No verified English nameHubei Cheng Tian Pharma Co., Ltd. romanizedY20180001209AExact ingredient2026/05/27CDE
盐酸普萘洛尔 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20180000739AExact ingredient—CDE
盐酸普萘洛尔 · No verified English nameIPCA LABORATORIES LIMITEDY20170001850AExact ingredient2025/03/29CDE
盐酸普萘洛尔 · No verified English nameHua Zhong Pharma Co., Ltd. romanizedY20170001428AExact ingredient2024/10/18CDE
盐酸普萘洛尔 · No verified English nameChangzhou Kang Pu Pharma Co., Ltd. romanizedY20170001018AExact ingredient2023/07/14CDE

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. 2026/10/16Accepted

    Shenyang Tian Bang Pharma Co., Ltd. romanized

    CYHS2602552

    Fact date: 2026/10/16 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/10/14Accepted

    Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized

    CYHS2602538

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    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.

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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