Flunisolide
Flunisolide Nasal Solution USP, 0.025% Rx only FOR INTRANASAL USE ONLY
Approved
Approval ID
f39cae46-c68f-47ef-82f3-4fd3dd46c74c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2020
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-317
Application NumberANDA207802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flunisolide
Product Specifications
Route of AdministrationNASAL
Effective DateJune 24, 2022
FDA Product Classification
INGREDIENTS (11)
FLUNISOLIDEActive
Quantity: 0.25 mg in 1 mL
Code: QK4DYS664X
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT