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Meloxicam

These highlights do not include all the information needed to use meloxicam tablets USP safely and effectively. See full prescribing information for meloxicam tablets USP.MELOXICAM tablets USP for oral use Initial U.S. Approval: 2000

Approved
Approval ID

d224143d-2199-4969-a64f-dc2e6b865ec4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 25, 2013

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

Products 1

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

Meloxicam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66116-443
Application NumberANDA077936
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2013
FDA Product Classification

INGREDIENTS (8)

MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT

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Meloxicam - FDA Drug Approval Details