Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
080189610
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals, LLC
QPharma Inc
Hikma Pharmaceuticals USA Inc.
036986393
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
42708-045Application Number
ANDA084122Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 8, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 10 mg in 1 1