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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

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Carboplatin - FDA Drug Approval Details