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Orange Book drug · Brand (NDA)

Airduo Digihaler

Fluticasone Propionate; Salmeterol Xinafoate

DiscontinuedRLDNDA 208799 3 strengths Teva Pharm
Approved
Jul 12, 2019
Strengths
3
Listed patents
14

What does the FDA Orange Book show for Airduo Digihaler?

Airduo Digihaler contains Fluticasone Propionate; Salmeterol Xinafoate and is the new drug FDA Orange Book record for NDA 208799. The application has 3 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 208799

New drug application identity from the Orange Book snapshot.

Application holder
Teva Pharmaceutical Industries Ltd

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
3

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Discontinued

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
14

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0040.055MG/INH;EQ 0.014MG BASE/INHPOWDERINHALATIONDiscontinuedNone posted
RLD
0050.113MG/INH;EQ 0.014MG BASE/INHPOWDERINHALATIONDiscontinuedNone posted
RLD
0060.232MG/INH;EQ 0.014MG BASE/INHPOWDERINHALATIONDiscontinuedNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Teva Pharmaceutical Industries Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 208799.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

3 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

14 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Jan 06, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

4 other ANDAs and 2 other NDAs found

3 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 208799 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-208799

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

3 approved presentations · NDA 208799
RLDDiscontinued
Strength
0.055MG/INH;EQ 0.014MG BASE/INH
Dosage form
POWDER
Route
INHALATION
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 2 mo ago

  2. Today

  3. Patent 10195375 expires

    Listed drug product patent expiration.

    in 4 yr 7 mo

  4. Patent 10195375*PED expires

    Listed listed patent expiration.

    in 5 yr 2 mo

  5. Patent 9066957 expires

    Listed drug product patent expiration.

    in 8 yr 4 mo

  6. Patent 9415008 expires

    Listed drug product patent expiration.

    in 8 yr 4 mo

  7. Patent 9066957*PED expires

    Listed listed patent expiration.

    in 8 yr 10 mo

  8. Patent 9415008*PED expires

    Listed listed patent expiration.

    in 8 yr 10 mo

  9. Patent 10918816 expires

    Listed drug product patent expiration.

    in 9 yr 6 mo

  10. Patent 10918816*PED expires

    Listed listed patent expiration.

    in 10 yr

  11. Patent 11969544 expires

    Listed drug product patent expiration.

    in 13 yr 3 mo

  12. Patent 11344685 expires

    Listed drug product patent expiration.

    in 13 yr 4 mo

  13. Patent 11969544*PED expires

    Listed listed patent expiration.

    in 13 yr 9 mo

  14. Patent 11344685*PED expires

    Listed listed patent expiration.

    in 13 yr 10 mo

  15. Patent 11173259 expires

    Listed drug product patent expiration.

    in 14 yr 2 mo

  16. Patent 11173259*PED expires

    Listed listed patent expiration.

    in 14 yr 8 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 10195375: 2031-02-14Patent 10195375Patent 10195375*PED: 2031-08-14Patent 10195375*PEDPatent 9066957: 2034-10-06Patent 9066957Patent 9415008: 2034-10-06Patent 9415008Patent 9066957*PED: 2035-04-06Patent 9066957*PEDPatent 9415008*PED: 2035-04-06Patent 9415008*PEDPatent 10918816: 2035-12-14Patent 10918816Patent 10918816*PED: 2036-06-14Patent 10918816*PEDPatent 11969544: 2039-08-20Patent 11969544Patent 11344685: 2039-09-26Patent 11344685Patent 11969544*PED: 2040-02-20Patent 11969544*PEDPatent 11344685*PED: 2040-03-26Patent 11344685*PEDPatent 11173259: 2040-07-06Patent 11173259Patent 11173259*PED: 2041-01-06Patent 11173259*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Strength

0.055MG/INH;EQ 0.014MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 208799

Product number

004

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10195375in 4 yr 7 mo
Product
10195375*PEDin 5 yr 2 mo
9066957in 8 yr 4 mo
ProductU-645
9415008in 8 yr 4 mo
ProductU-645
9066957*PEDin 8 yr 10 mo
9415008*PEDin 8 yr 10 mo
10918816in 9 yr 6 mo
Product
10918816*PEDin 10 yr
11969544in 13 yr 3 mo
Product
11344685in 13 yr 4 mo
Product
11969544*PEDin 13 yr 9 mo
11344685*PEDin 13 yr 10 mo
11173259in 14 yr 2 mo
Product
11173259*PEDin 14 yr 8 mo

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Fluticasone Propionate; Salmeterol Xinafoate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Airduo Digihaler: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 208799 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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