Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals
Northwind Pharmaceuticals
Northwind Pharmaceuticals
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
51655-763Application Number
ANDA087801Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 2.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT