CIPROFLOXACIN HYDROCHLORIDE
0.3% as baseSterile
Approved
Approval ID
11f56251-d913-4986-9dba-c2e4df8a3822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CIPROFLOXACIN HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code16590-421
Application NumberNDA019992
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateOctober 11, 2012
Generic NameCIPROFLOXACIN HYDROCHLORIDE
INGREDIENTS (9)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3.5 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT