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AirDuo RespiClick

Fluticasone Propionate and Salmeterol · Powder, Metered

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
AirDuo RespiClick
Generic name
Fluticasone Propionate and Salmeterol
Dosage form
Powder, Metered
Route
Respiratory (Inhalation)
Marketing category
NDA · NDA
Labeler
Teva Respiratory, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Fluticasone Propionate 113 ug/1 1797907 View
Fluticasone Propionate 232 ug/1 1797907 View
Fluticasone Propionate 55 ug/1 1797907 View
Salmeterol Xinafoate 14 ug/1 896184 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder, Metered
Route of administration
Respiratory (Inhalation)
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic beta2-Agonists [MoA] MoA All 37 members
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members
beta2-Adrenergic Agonist [EPC] EPC All 37 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208799
Application type
NDA · New Drug Application
Approval date
January 27, 2017
Sponsor
TEVA PHARM
Products on application
6
Submissions recorded
7
Products approved under application 208799.
Product Trade name Form Strength Ingredient Status TE Flags
208799-001 AIRDUO RESPICLICK POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Prescription — RLD RS
208799-002 AIRDUO RESPICLICK POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Prescription — RLD RS
208799-003 AIRDUO RESPICLICK POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Prescription — RLD RS
208799-004 AIRDUO DIGIHALER POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Discontinued — RLD
208799-005 AIRDUO DIGIHALER POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Discontinued — RLD
208799-006 AIRDUO DIGIHALER POWDER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Discontinued — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10195375 February 14, 2031 001 No March 5, 2019
10195375 February 14, 2031 002 No March 5, 2019
10195375 February 14, 2031 003 No March 5, 2019
10195375 February 14, 2031 004 No August 2, 2019
10195375 February 14, 2031 005 No August 2, 2019
10195375 February 14, 2031 006 No August 2, 2019
10195375*PED August 14, 2031 001 No —
10195375*PED August 14, 2031 002 No —
10195375*PED August 14, 2031 003 No —
10195375*PED August 14, 2031 004 No —
10195375*PED August 14, 2031 005 No —
10195375*PED August 14, 2031 006 No —
9415008 October 6, 2034 001 No U-645 January 30, 2017
9066957 October 6, 2034 001 No U-645 January 30, 2017
9066957 October 6, 2034 002 No U-645 January 30, 2017
9066957 October 6, 2034 003 No U-645 January 30, 2017
9415008 October 6, 2034 004 No U-645 August 2, 2019
9066957 October 6, 2034 004 No U-645 August 2, 2019
9066957 October 6, 2034 005 No U-645 August 2, 2019
9066957 October 6, 2034 006 No U-645 August 2, 2019
9415008*PED April 6, 2035 001 No —
9066957*PED April 6, 2035 001 No —
9066957*PED April 6, 2035 002 No —
9066957*PED April 6, 2035 003 No —
9415008*PED April 6, 2035 004 No —
9066957*PED April 6, 2035 004 No —
9066957*PED April 6, 2035 005 No —
9066957*PED April 6, 2035 006 No —
10918816 December 14, 2035 004 No March 18, 2021
10918816 December 14, 2035 005 No March 18, 2021
10918816 December 14, 2035 006 No March 18, 2021
10918816*PED June 14, 2036 004 No —
10918816*PED June 14, 2036 005 No —
10918816*PED June 14, 2036 006 No —
11969544 August 20, 2039 001 No May 29, 2024
11969544 August 20, 2039 002 No May 29, 2024
11969544 August 20, 2039 003 No May 29, 2024
11969544 August 20, 2039 004 No May 29, 2024
11969544 August 20, 2039 005 No May 29, 2024
11969544 August 20, 2039 006 No May 29, 2024
11344685 September 26, 2039 004 No June 29, 2022
11344685 September 26, 2039 005 No June 29, 2022
11344685 September 26, 2039 006 No June 29, 2022
11969544*PED February 20, 2040 001 No —
11969544*PED February 20, 2040 002 No —
11969544*PED February 20, 2040 003 No —
11969544*PED February 20, 2040 004 No —
11969544*PED February 20, 2040 005 No —
11969544*PED February 20, 2040 006 No —
11344685*PED March 26, 2040 004 No —
11344685*PED March 26, 2040 005 No —
11344685*PED March 26, 2040 006 No —
11173259 July 6, 2040 004 No December 8, 2021
11173259 July 6, 2040 005 No December 8, 2021
11173259 July 6, 2040 006 No December 8, 2021
11173259*PED January 6, 2041 004 No —
11173259*PED January 6, 2041 005 No —
11173259*PED January 6, 2041 006 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 208799.
Type No. Action Status Date Review
Supplement 26 Labeling Approved November 16, 2023 Standard
Supplement 19 Labeling Approved January 27, 2022 Standard
Supplement 21 Efficacy Approved July 9, 2021 Standard
Supplement 11 Labeling Approved February 21, 2020 Standard
Supplement 1 Labeling Approved March 2, 2018 Standard
Supplement 2 Labeling Approved December 20, 2017 Standard
Original application 1 Type 4 - New Combination Approved January 27, 2017 Standard

Review documents

  • 0 · Supplement · November 20, 2023
  • 0 · Supplement · November 17, 2023
  • 0 · Supplement · March 17, 2022
  • 0 · Supplement · March 10, 2022
  • 0 · Supplement · July 13, 2021
  • 0 · Supplement · July 12, 2021
  • 0 · Supplement · February 27, 2020
  • 0 · Supplement · February 25, 2020
  • 0 · Supplement · March 12, 2018
  • 0 · Supplement · March 6, 2018
  • 0 · Supplement · December 27, 2017
  • 0 · Supplement · December 22, 2017
  • 0 · Original application · April 14, 2017
  • 0 · Original application · January 31, 2017
  • 0 · Original application · January 27, 2017
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Adverse event reports

Source: openFDA FAERS
224,191
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FLUTICASONE PROPIONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59310-805-06 59310-805 Teva Respiratory, LLC 1 POUCH in 1 CARTON (59310-805-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER April 24, 2017
59310-812-06 59310-812 Teva Respiratory, LLC 1 POUCH in 1 CARTON (59310-812-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER April 24, 2017
59310-822-06 59310-822 Teva Respiratory, LLC 1 POUCH in 1 CARTON (59310-822-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER April 24, 2017
59310-805 59310-805 Teva Respiratory, LLC — April 12, 2017
59310-812 59310-812 Teva Respiratory, LLC — April 20, 2017
59310-822 59310-822 Teva Respiratory, LLC — April 12, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.