You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203433


✉ Email this page to a colleague

« Back to Dashboard


NDA 203433 describes FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, which is a drug marketed by Hikma and Teva Pharms Usa and is included in two NDAs. It is available from four suppliers. Additional details are available on the FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 203433
Pharmacology for NDA: 203433
Suppliers and Packaging for NDA: 203433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 203433 ANDA Hikma Pharmaceuticals USA Inc. 0054-0326 0054-0326-56 1 POUCH in 1 CARTON (0054-0326-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 203433 ANDA Hikma Pharmaceuticals USA Inc. 0054-0327 0054-0327-56 1 POUCH in 1 CARTON (0054-0327-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date:Dec 17, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date:Dec 17, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date:Dec 19, 2023TE:ABRLD:No

Complete Access Available with Subscription

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

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.