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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 078492


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NDA 078492 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Chartwell Rx, Taro Pharm Inds, Apotex, Aurobindo Pharma Ltd, Hikma, Rubicon, Rubicon Research, and Teva Pharms Usa, and is included in twenty-four NDAs. It is available from sixty-eight suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 078492
Tradename:FLUTICASONE PROPIONATE
Applicant:Chartwell Rx
Ingredient:fluticasone propionate
Patents:0
Pharmacology for NDA: 078492
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 078492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 078492 ANDA Chartwell RX, LLC 62135-810 62135-810-61 1 BOTTLE, SPRAY in 1 CARTON (62135-810-61) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 078492 ANDA NuCare Pharmaceuticals,Inc. 68071-1638 68071-1638-5 16 SPRAY, METERED in 1 BOX (68071-1638-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Jan 9, 2012TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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