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Sign in to subscribeSalmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation
Matched- Active ingredients (original)
- FLUTICASONE PROPIONATE · SALMETEROL XINAFOATE
- Dosage form (original)
- POWDER
- Route (original)
- INHALATION
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval2000/08/24
ANDA applications5
RLD applicantGLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE / TEVA PHARMACEUTICAL INDUSTRIES LTD
Currently marketed products: 20 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A203433-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2020/12/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203433-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2020/12/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203433-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | HIKMA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2023/12/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-001 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-002 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208891-003 | WIXELA INHUB | MYLAN PHARMACEUTICALS INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2019/01/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213087-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | CIPLA LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213948-003 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | TEVA PHARMACEUTICALS USA INC | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2021/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214464-001 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | RESPIRENT PHARMACEUTICALS CO LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/01/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214464-002 | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | RESPIRENT PHARMACEUTICALS CO LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2026/01/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-001 | ADVAIR DISKUS 100/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.1MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-002 | ADVAIR DISKUS 250/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.25MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021077-003 | ADVAIR DISKUS 500/50 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.5MG/INH SALMETEROL XINAFOATE: EQ 0.05MG BASE/INH | 2000/08/24 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-001 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.055MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-002 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.113MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-003 | AIRDUO RESPICLICK | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.232MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2017/01/27 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208799-004 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.055MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N208799-005 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.113MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N208799-006 | AIRDUO DIGIHALER | TEVA PHARMACEUTICAL INDUSTRIES LTD | POWDER | INHALATION | FLUTICASONE PROPIONATE: 0.232MG/INH SALMETEROL XINAFOATE: EQ 0.014MG BASE/INH | 2019/07/12 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2041/01/06This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| N208799-001 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-001 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-001 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-001 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-001 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-001 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-001 | 9415008 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-001 | 9415008*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-002 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-002 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-002 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-002 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-002 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-002 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-003 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-003 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-003 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-003 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-003 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-003 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-004 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-004 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-004 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-004 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-004 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-004 | 9415008 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-004 | 9415008*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-005 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-005 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-005 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-005 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-005 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-005 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
| N208799-006 | 10195375 | 2031/02/14 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 10195375*PED | 2031/08/14 | — / — | — | — | openFDA ↗ |
| N208799-006 | 10918816 | 2035/12/14 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 10918816*PED | 2036/06/14 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11173259 | 2040/07/06 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11173259*PED | 2041/01/06 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11344685 | 2039/09/26 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11344685*PED | 2040/03/26 | — / — | — | — | openFDA ↗ |
| N208799-006 | 11969544 | 2039/08/20 | — / Y | — | — | openFDA ↗ |
| N208799-006 | 11969544*PED | 2040/02/20 | — / — | — | — | openFDA ↗ |
| N208799-006 | 9066957 | 2034/10/06 | — / Y | U-645 | — | openFDA ↗ |
| N208799-006 | 9066957*PED | 2035/04/06 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Laboratoire GlaxoSmithKline | 国药准字HJ20150323See source | — | Official source ↗ |
| M/s. Cipla Limited | 国药准字HJ20250075See source | — | Official source ↗ |
| Sichuan Pu Rui Te Pharma Co., Ltd. romanized | 国药准字H20253521See source | — | Official source ↗ |
| Health Yuan Pharma Group Co., Ltd. romanized | 国药准字H20243906See source | — | Official source ↗ |
| Shanghai Ou Mi Ni Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255235See source | — | Official source ↗ |
| Neutec Ilac San. Tic. A.S. | 国药准字HJ20240136See source | — | Official source ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150324See source | — | Official source ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150325See source | — | Official source ↗ |
| M/s. Cipla Limited | 国药准字HJ20250076See source | — | Official source ↗ |
| Neutec Ilac San. Tic. A.S. | 国药准字HJ20240137See source | — | Official source ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150323See source | — | Official source ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150324See source | — | Official source ↗ |
| Laboratoire GlaxoSmithKline | 国药准字HJ20150325See source | — | Official source ↗ |
| M/s. Cipla Limited | 国药准字HJ20250077See source | — | Official source ↗ |
Under review 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | CYHS2600253 | 2026/01/22 | Official source ↗ |
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | CYHS2600252 | 2026/01/22 | Official source ↗ |
| Celon Pharma S.A.; Jiangsu Simcere Pharmaceutical Co. Ltd. | JYHS2400054 | 2024/10/30 | Official source ↗ |
| Celon Pharma S.A.; Jiangsu Simcere Pharmaceutical Co. Ltd. | JYHS2400053 | 2024/10/30 | Official source ↗ |
| Run Sheng Pharma Co., Ltd. romanized | CYHS2602496 | 2026/10/12 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2600460 | 2026/08/12 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2600459 | 2026/08/12 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2600458 | 2026/08/12 | Official source ↗ |
| Sichuan Pu Rui Te Pharma Co., Ltd. romanized | CYHB2600789 | 2026/04/22 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2500545 | 2025/10/17 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2500544 | 2025/10/17 | Official source ↗ |
| Laboratoire GlaxoSmithKline; Glaxo Wellcome Production | JYHB2500543 | 2025/10/17 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | CYHS2600253 | 2026/01/22 | Official source ↗ |
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | CYHS2600252 | 2026/01/22 | Official source ↗ |
| Run Sheng Pharma Co., Ltd. romanized | CYHS2602496 | 2026/10/12 | Official source ↗ |
API companies with A status 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Formulation crosswalk to POWDER / INHALATION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-047. Chinese Pharmacopoeia general chapter 0111
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 39-26 · 2021/03/03
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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