Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Moodys
Merck
Harvard Business School
Boehringer Ingelheim

Last Updated: February 4, 2023

Details for New Drug Application (NDA): 208799


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 208799 describes AIRDUO RESPICLICK, which is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are sixteen patents protecting this drug. Additional details are available on the AIRDUO RESPICLICK profile page.

The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 208799
Pharmacology for NDA: 208799
Suppliers and Packaging for NDA: 208799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3607 0093-3607-82 1 POUCH in 1 CARTON (0093-3607-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3607 0093-3607-82 1 POUCH in 1 CARTON (0093-3607-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.055MG/INH;EQ 0.014MG BASE/INH
Approval Date:Jan 27, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 9, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jul 9, 2024
Regulatory Exclusivity Use:REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Patent:See Plans and PricingPatent Expiration:Nov 18, 2031Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 208799

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
McKinsey
Johnson and Johnson
Medtronic
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.