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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 203433


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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

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