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BECONASE

BECONASE (beclomethasone dipropionate monohydrate) spray, suspension

Approved
Approval ID

6e8f7981-f2ca-4b56-8759-4f18cf9706c8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 8, 2010

Manufacturers
FDA

Stat Rx USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

beclomethasone dipropionate monohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-030
Application NumberNDA019389
Product Classification
M
Marketing Category
C73594
G
Generic Name
beclomethasone dipropionate monohydrate
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 8, 2010
FDA Product Classification

INGREDIENTS (7)

BECLOMETHASONE DIPROPIONATE MONOHYDRATEActive
Quantity: 42 ug in 1 1
Code: 4H7L9AI22I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PHENETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

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BECONASE - FDA Drug Approval Details