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FDA Approval

Meloxicam

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 19, 2018
Labeling Type
Human Prescription Drug Label
Meloxicam(15 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Ascent Pharmaceuticals Inc.

Exelan Pharmaceuticals Inc.

080938961

Products2

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

Meloxicam

Product Details

NDC Product Code
76282-153
Application Number
ANDA077927
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 17, 2023
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 15 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Meloxicam

Product Details

NDC Product Code
76282-152
Application Number
ANDA077927
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 17, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 7.5 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
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