Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Chiesi Farmaceutici S.p.A
439554411
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamzede
Product Details
NDC Product Code
10122-180Application Number
BLA761278Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
February 27, 2023SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74Class: IACTQuantity: 2.47 mg in 1 1
GLYCINEInactive
Code: TE7660XO1CClass: IACTQuantity: 10.1 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 227.5 mg in 1 1
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SWClass: IACTQuantity: 0.088 mg in 1 1
Velmanase alfaActive
Code: M91TG242P2Class: ACTIBQuantity: 10 mg in 1 1
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
CONTRAINDICATIONS SECTION
Highlight: None. (4)
4****CONTRAINDICATIONS
None.