MedPath
FDA Approval

PREDNISONE

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

FDA Approval Summary

Company
Effective Date
September 16, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prednisone(20 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

PREDNISONE

Product Details

NDC Product Code
50090-4784
Application Number
ANDA210525
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 30, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: VB0R961HZTClass: ACTIBQuantity: 20 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
© Copyright 2025. All Rights Reserved by MedPath