Pulmotech MAA
These highlights do not include all the information needed to use PULMOTECH™ MAA safely and effectively. See full prescribing information for PULMOTECH MAA. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated ) injection, for intravenous or intraperitoneal use. Initial U.S. Approval: 2020
Approved
Approval ID
a8b7adf0-2c6b-4acd-96d3-a099306951a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Curium US LLC
DUNS: 079875617
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
kit for the preparation of technetium Tc 99m albumin aggregated
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69945-139
Application NumberBLA210089
Product Classification
M
Marketing Category
C73585
G
Generic Name
kit for the preparation of technetium Tc 99m albumin aggregated
Product Specifications
Route of AdministrationINTRAPERITONEAL, INTRAVENOUS
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (4)
ALBUMIN AGGREGATEDActive
Quantity: 2 mg in 15 mL
Code: 799C8VF17R
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 15 mL
Code: 451W47IQ8X
Classification: IACT
ALBUMIN HUMANInactive
Quantity: 7.1 mg in 15 mL
Code: ZIF514RVZR
Classification: IACT
STANNOUS CHLORIDEInactive
Quantity: 0.1 mg in 15 mL
Code: 1BQV3749L5
Classification: IACT