FLUTICASONE
FLUTICASONE PROPIONATE SPRAY
Approved
Approval ID
ab7529ac-fa19-4be8-9906-8889fa3e8398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2019
Manufacturers
FDA
Direct RX
DUNS: 079254320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLUTICASONE
PRODUCT DETAILS
NDC Product Code61919-611
Application NumberANDA076504
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateApril 9, 2019
Generic NameFLUTICASONE
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE
PRODUCT DETAILS
NDC Product Code61919-004
Application NumberANDA078492
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateApril 9, 2019
Generic NameFLUTICASONE
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
FLUTICASONE
PRODUCT DETAILS
NDC Product Code61919-620
Application NumberANDA077570
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateApril 9, 2019
Generic NameFLUTICASONE
INGREDIENTS (8)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 0.1 g
Code: O2GMZ0LF5W
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT