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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

77ce6445-9f4f-4e9a-e053-2a91aa0a8903

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2023

Manufacturers
FDA

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

DUNS: 080355546

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 Code70934-010
Application NumberANDA077927
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB

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meloxicam - FDA Drug Approval Details