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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215878


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NDA 215878 describes MOMETASONE FUROATE, which is a drug marketed by Anda Repository, Cosette, Fougera Pharms, Glenmark Pharms Inc, Taro, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, and Aurobindo Pharma, and is included in twenty-three NDAs. It is available from thirteen suppliers. Additional details are available on the MOMETASONE FUROATE profile page.

The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 215878
Tradename:MOMETASONE FUROATE
Applicant:Aurobindo Pharma
Ingredient:mometasone furoate
Patents:0
Pharmacology for NDA: 215878
Medical Subject Heading (MeSH) Categories for 215878
Suppliers and Packaging for NDA: 215878
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOMETASONE FUROATE mometasone furoate SPRAY, METERED;NASAL 215878 ANDA Aurobindo Pharma Limited 59651-402 59651-402-17 1 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Mar 18, 2024TE:ABRLD:No

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