Carboplatin
CARBOPLATIN- carboplatin injection, solution
Approved
Approval ID
f4baa639-287b-4d97-923f-ce5c6add531c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2016
Manufacturers
FDA
Sanja Pharmaceuticals Company
DUNS: 078741518
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carboplatin Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57277-105
Application NumberANDA205487
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboplatin Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2016
FDA Product Classification
INGREDIENTS (3)
CARBOPLATINActive
Quantity: 50 mg in 5 mL
Code: BG3F62OND5
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
carboplatin Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57277-107
Application NumberANDA205487
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboplatin Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2016
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CARBOPLATINActive
Quantity: 450 mg in 5 mL
Code: BG3F62OND5
Classification: ACTIB
carboplatin Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57277-106
Application NumberANDA205487
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboplatin Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2016
FDA Product Classification
INGREDIENTS (3)
CARBOPLATINActive
Quantity: 150 mg in 5 mL
Code: BG3F62OND5
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT