FDA Product

carboplatin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

carboplatin

FDA Product Code

47335-150

Regulatory Information

NDC Product Code

47335-150

Application Number

ANDA077926

Marketing Category

C73584

Effective Date

October 25, 2018

Territorial Authority

USA

FDA Title

Carboplatin Injection

Labeling Type

Human Prescription Drug Label

Version Number

3

Company Information

ManufacturerSun Pharmaceutical Industries, Inc.

DUNS Number

146974886

Active Ingredients

Quantity: 10 mg in 1 mL

Code: BG3F62OND5

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CARBOPLATIN

Code: BG3F62OND5

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