Flunisolide
FlunisolideNasal Solution USP, 0.025%
Approved
Approval ID
e2cad5b9-0a9b-4b62-8146-c60204798370
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flunisolide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4799
Application NumberANDA074805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flunisolide
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (11)
FLUNISOLIDEActive
Quantity: 0.25 mg in 1 mL
Code: QK4DYS664X
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT