MILLIPRED
MILLIPRED™ Tablet (prednisolone tablets USP) Rx only
Approved
Approval ID
b9a97cfa-53a3-4080-98da-7cca8ba1e0fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Avalo Therapeutics Inc.
DUNS: 968799028
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PREDNISOLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73534-505
Application NumberANDA080354
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREDNISOLONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
PREDNISOLONEActive
Quantity: 5 mg in 1 1
Code: 9PHQ9Y1OLM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT