MedPath

CARBOPLATIN

CARBOPLATIN- carboplatin injection, solutionRx only

Approved
Approval ID

9eb057eb-29ce-40d2-9ac8-ed107f25f5ab

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 18, 2017

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

Products 4

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 Code68083-191
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 18, 2017
FDA Product Classification

INGREDIENTS (2)

CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Carboplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-190
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 18, 2017
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB

Carboplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-193
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 18, 2017
FDA Product Classification

INGREDIENTS (2)

CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Carboplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-192
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 18, 2017
FDA Product Classification

INGREDIENTS (2)

CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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CARBOPLATIN - FDA Drug Approval Details