Ciprofloxacin and dexamethasone
These highlights do not include all the information needed to use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION safely and effectively. See full prescribing information for CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION. CIPROFLOXACIN and DEXAMETHASONE otic suspension Initial U.S. Approval: 2003
Approved
Approval ID
eed6b293-6bbe-4bd3-ad9d-3849e0eb6c05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
ARMAS PHARMACEUTICALS INC.
DUNS: 098405973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciprofloxacin and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72485-625
Application NumberANDA215768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin and dexamethasone
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (13)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB