Carboplatin
Carboplatin Injection(carboplatin aqueous solution)
Approved
Approval ID
81757808-f609-40d1-a4c1-08b32234719f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2022
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-100
Application NumberANDA077096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (2)
waterInactive
Code: 059QF0KO0R
Classification: IACT
carboplatinActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB