RYCLORA
RYCLORA™ (dexchlorpheniramine maleate) Oral Solution, USP
Approved
Approval ID
aa4f80c9-e600-4bc0-8528-02a8162a36f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
CARWIN PHARMACEUTICAL ASSOCIATES, LLC
DUNS: 079217215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexchlorpheniramine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-150
Application NumberANDA202520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexchlorpheniramine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (11)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Dexchlorpheniramine MaleateActive
Quantity: 2 mg in 5 mL
Code: B10YD955QW
Classification: ACTIB
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
menthol, unspecified formInactive
Code: L7T10EIP3A
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT