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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

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Carboplatin - FDA Drug Approval Details