Details for New Drug Application (NDA): 210470

NDA 210470 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 five 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. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for 210470

Tradename:	CIPROFLOXACIN AND DEXAMETHASONE
Applicant:	Sun Pharm
Ingredient:	ciprofloxacin; dexamethasone
Patents:	0

Pharmacology for NDA: 210470

Mechanism of Action

Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors

Suppliers and Packaging for NDA: 210470

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	210470	ANDA	Sun Pharmaceutical Industries, Inc.	62756-427	62756-427-90	1 BOTTLE, DROPPER in 1 CARTON (62756-427-90) / 7.5 mL in 1 BOTTLE, DROPPER
CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	210470	ANDA	RedPharm Drug	67296-1888	67296-1888-8	8 mL in 1 CARTON (67296-1888-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OTIC			Strength	0.3%;0.1%
Approval Date:	Aug 30, 2022	TE:	AB	RLD:	No

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