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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211815

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NDA 211815 describes FLUOCINONIDE ACETONIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUOCINONIDE ACETONIDE profile page.

The generic ingredient in FLUOCINONIDE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 211815
Applicant:Glenmark Pharms Ltd
Ingredient:fluocinolone acetonide
Formulation / Manufacturing:see details
Pharmacology for NDA: 211815
Medical Subject Heading (MeSH) Categories for 211815
Suppliers and Packaging for NDA: 211815
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 211815 ANDA Glenmark Pharmaceuticals Inc., USA 68462-185 68462-185-56 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) > 20 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL/DROPS;OTICStrength0.01%
Approval Date:Dec 14, 2018TE:ATRLD:No

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