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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205548


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NDA 205548 describes CIPROFLOXACIN AND DEXAMETHASONE, which is a drug marketed by Dr Reddys, Sentiss, and Sun Pharm, and is included in three NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN AND DEXAMETHASONE profile page.

The generic ingredient in CIPROFLOXACIN AND DEXAMETHASONE is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 205548
Pharmacology for NDA: 205548
Suppliers and Packaging for NDA: 205548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 205548 ANDA NorthStar RxLLC 16714-628 16714-628-01 1 BOTTLE, DROPPER in 1 CARTON (16714-628-01) / 7.5 mL in 1 BOTTLE, DROPPER
CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 205548 ANDA Dr. Reddy's Laboratories, Inc. 43598-326 43598-326-75 1 BOTTLE, DROPPER in 1 CARTON (43598-326-75) / 7.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength0.3%;0.1%
Approval Date:Aug 10, 2020TE:ABRLD:No

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