Carboplatin
CARBOplatin Injection
Approved
Approval ID
e176b6ef-2ff6-498b-a9d8-7a634d147f37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2022
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
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 Code0703-4239
Application NumberANDA077269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (3)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
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 Code0703-4248
Application NumberANDA077269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (3)
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-4244
Application NumberANDA077269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (3)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
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 Code0703-4246
Application NumberANDA077269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (3)
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT