Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
081225162
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEONATAL19
Product Details
NDC Product Code
73317-8242Route of Administration
ORALEffective Date
September 25, 2020ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.5 mg in 1 1
RiboflavinActive
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Vitamin B12Active
Code: P6YC3EG204Class: ACTIBQuantity: 6 ug in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 150 ug in 1 1
Pantothenic acidActive
Code: 568ET80C3DClass: ACTIMQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 1 1
NicotinamideActive
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 10 mg in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 1000 ug in 1 1
OPADRY YS-1-12726A YELLOWInactive
Code: PLG7GLN7QIClass: IACT