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