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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210556


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NDA 210556 describes FLUCINOLONE ACETONIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the FLUCINOLONE ACETONIDE profile page.

The generic ingredient in FLUCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 210556
Tradename:FLUCINOLONE ACETONIDE
Applicant:Glenmark Pharms Ltd
Ingredient:fluocinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210556
Medical Subject Heading (MeSH) Categories for 210556
Suppliers and Packaging for NDA: 210556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 210556 ANDA Glenmark Pharmaceuticals Inc., USA 68462-591 68462-591-89 1 BOTTLE in 1 CARTON (68462-591-89) / 118.28 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:Oct 25, 2018TE:ATRLD:No

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