RHINOCORT AQUA
RHINOCORT AQUA 32 mcg (budesonide) Nasal Spray.INITIAL U.S. APPROVAL: 1999
Approved
Approval ID
ffca32a2-fbef-40bb-b0f0-73f63e18e747
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 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.
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4411
Application NumberNDA020746
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationNASAL
Effective DateFebruary 7, 2012
FDA Product Classification
INGREDIENTS (9)
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BUDESONIDEActive
Quantity: 32 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT