MedPath
FDA Approval

Hemady

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

FDA Approval Summary

Company
Effective Date
June 1, 2023
Labeling Type
Human Prescription Drug Label
Dexamethasone(20 mg in 1 1)

Products1

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

Hemady

Product Details

NDC Product Code
82111-955
Application Number
NDA211379
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 1, 2023
Code: 7S5I7G3JQLClass: ACTIBQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
© Copyright 2025. All Rights Reserved by MedPath