MedPath
FDA Approval

Meloxicam

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

FDA Approval Summary

Company
Effective Date
July 5, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Meloxicam(15 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

PSS World Medical, Inc.

101822682

Manufacturing Establishments1

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

Dispensing Solutions, Inc.

Dispensing Solutions, Inc.

PSS World Medical, Inc.

066070785

Products1

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
66336-774
Application Number
ANDA077918
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 3, 2013
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 15 mg in 1 1
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2Class: IACT
LactoseInactive
Code: J2B2A4N98GClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61UClass: IACT
Povidone K30Inactive
Code: U725QWY32XClass: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULRClass: IACT
© Copyright 2025. All Rights Reserved by MedPath