Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Diect_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Diect_Rx
Diect_Rx
Diect_Rx
079254320
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
61919-326Application Number
ANDA085161Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 7, 2019CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 20 mg in 1 1
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT