PARAPLATIN
PARAPLATIN (carboplatin) Injection Rx only
Approved
Approval ID
f88e0483-09be-4f60-be8f-964c02e3ece0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2022
Manufacturers
FDA
Accord BioPharma Inc.
DUNS: 079636487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69448-005
Application NumberANDA206775
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (2)
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT