Paclitaxel
Paclitaxel Injection USP
Approved
Approval ID
e4be6cbf-72b9-4f7f-9b1b-459b2d35961a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2015
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.
Paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-3218
Application NumberANDA075184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2015
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PACLITAXELActive
Quantity: 6 mg in 1 mL
Code: P88XT4IS4D
Classification: ACTIB
Paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-3216
Application NumberANDA075184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2015
FDA Product Classification
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PACLITAXELActive
Quantity: 6 mg in 1 mL
Code: P88XT4IS4D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
Paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-3217
Application NumberANDA075184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2015
FDA Product Classification
INGREDIENTS (4)
PACLITAXELActive
Quantity: 6 mg in 1 mL
Code: P88XT4IS4D
Classification: ACTIB
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
Paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-3213
Application NumberANDA075184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2015
FDA Product Classification
INGREDIENTS (4)
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
PACLITAXELActive
Quantity: 6 mg in 1 mL
Code: P88XT4IS4D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT