Monthly
US$200
Billed every month
Sign in to subscribeAs of 13 November 2026, for Brimonidine Tartrate Eye Drops, 4 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 2 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as ALPHAGAN P (NDA 021262, ABBVIE INC).
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 applicationsNo longer listed under review: 1 application
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 5 of 6 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: Eye Drops. 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 |
|---|---|---|---|---|---|---|
| ALPHAGAN P | ABBVIE INC | NDA 021262 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN PRESCRIPTION DRUG | 2001/03/16 |
| ALPHAGAN P | ABBVIE INC | NDA 021770 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN PRESCRIPTION DRUG | 2005/08/19 |
| QOLIANA | SANDOZ INC | NDA 021764 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN PRESCRIPTION DRUG | 2006/05/22 |
| LUMIFY | BAUSCH AND LOMB INC | NDA 208144 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN OTC DRUG | 2017/12/22 |
| LUMIFY PRESERVATIVE FREE | BAUSCH AND LOMB INC | NDA 218424 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN OTC DRUG | 2024/04/19 |
| ALPHAGAN | ALLERGAN INC | NDA 020613 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | DISCONTINUED | 1996/09/06 |
| ALPHAGAN | ALLERGAN INC | NDA 020490 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | DISCONTINUED | 1997/03/13 |
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: 2 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Allergan Inc. | Allergan Sales, LLC | H20160425 | 2009/08/19 | 0.15% | Imported originator drug | CDE |
| Allergan Inc. | Allergan Sales, LLC | H20160426 | 2009/08/19 | 0.15% | Imported originator drug | CDE |
| Allergan Pharmaceuticals Ireland | Allergan Pharmaceuticals Ireland | H20160681 | 2003/06/02 | 5ml:10mg | 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.
Loaded records: 18 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangdong Zhong Sheng Pharma Co., Ltd. romanized | 国药准字H20253121 | 0.2%(5ml∶10mg) | Category B | XS01EAX174G010010100371 | NHSA |
| Wuxi Ji Yu Shan He Pharma Co., Ltd. romanized | 国药准字H20080439 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010101565 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20253730 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010102733 | NHSA |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H20080076 | 5ml :10mg | Category B | XS01EAX174G010010104010 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20213279 | 0.15%(0.3ml:0.45mg) | Category B | XS01EAX174G010010104021 | NHSA |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | 国药准字H20163241 | 5ml:10mg | Category B | XS01EAX174G010010109909 | NHSA |
| Sandoz Inc. | H20150504 | 5ml:10mg | Category B | XS01EAX174G010010178196 | NHSA |
| AbbVie Inc. | 国药准字HJ20160426 | 0.15%(5ml:7.5mg) | Category B | XS01EAX174G010010178204 | NHSA |
| AbbVie Limited | 国药准字HJ20160681 | 5ml:10mg | Category B | XS01EAX174G010010178976 | NHSA |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20255513 | 0.15%(0.3ml:0.45mg) | Category B | XS01EAX174G010010180537 | NHSA |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H20264756 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010181656 | NHSA |
| Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 国药准字H20243347 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010183124 | NHSA |
| Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized | 国药准字H20253272 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010183539 | NHSA |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249123 | See source | Category B | XS01EAX174G010010183562 | NHSA |
| Beijing Nuo Si Lan De Bio Technology Co., Ltd. romanized | 国药准字H20243152 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010183698 | NHSA |
| Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized | 国药准字H20243748 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010184070 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254308 | 0.2%(5ml:10mg) | Category B | XS01EAX174G010010184221 | NHSA |
| Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H20249428 | 0.15%(0.3ml:0.45mg) | Category B | XS01EAX174G010010184458 | 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: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2602311 | Generic | 2026/09/17 | Not stated by source | CDE |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | CYHS2600159 | Generic | 2026/01/13 | Not stated by source | CDE |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | CYHS2602385 | Generic | 2026/09/22 | Not stated by source | CDE |
| Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized | CYHL2600102 | Generic | 2026/09/22 | Not stated by source | CDE |
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2602311 | Generic | 2026/09/17 | Not stated by source | CDE |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | CYHS2600159 | Generic | 2026/01/13 | Not stated by source | CDE |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | CYHS2602385 | Generic | 2026/09/22 | Not stated by source | CDE |
| Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized | CYHL2600102 | Generic | 2026/09/22 | Not stated by source | CDE |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHL2600009 | Generic | 2026/01/13 | Not stated by source | CDE |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHL2600008 | Generic | 2026/01/13 | Not stated by source | CDE |
Non-component matches: 7 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 酒石酸溴莫尼定 · No verified English name | C-SQUARED PHARMA LIMITED | Y20240000181 | A | Exact ingredient | 2026/02/25 | CDE |
| 酒石酸溴莫尼定 · No verified English name | Shijiazhuang Gree Pharmaceutical Co., Ltd | Y20230001184 | A | Exact ingredient | 2026/06/02 | CDE |
| 酒石酸溴莫尼定 · No verified English name | CZECH-GEN, a.s. | Y20210000747 | A | Exact ingredient | 2026/10/16 | CDE |
| 酒石酸溴莫尼定 · No verified English name | Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190007214 | A | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 · No verified English name | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | Y20190007183 | A | Exact ingredient | 2025/12/04 | CDE |
| 酒石酸溴莫尼定 · No verified English name | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20190007132 | A | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 · No verified English name | Chengdu Xin Yue Pharmaceuticals Co., Ltd. romanized | Y20170001125 | I | Exact ingredient | — | CDE |
| 酒石酸溴莫尼定 · No verified English name | Indoco Remedies Ltd. (Kilo Lab) | Y20170000909 | A | Exact ingredient | 2026/04/02 | 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.
CYHS2501496 · 国药准字H20266463
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 54 ↗CYHS2502464
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2025/07/11
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2602385
Fact date: 2026/09/22 · Site observation date: 2026/10/21
View source ↗CYHL2600102
Fact date: 2026/09/22 · Site observation date: 2026/10/22
View source ↗CYHS2602311
Fact date: 2026/09/17 · Site observation date: 2026/10/21
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