PACLITAXEL
Paclitaxel Injection, USP(Patient Information Included)Rx only
Approved
Approval ID
fec9ddee-53a9-4a61-ad0a-be6b604de084
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2016
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 3
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 Code68083-179
Application NumberANDA207326
Product Classification
M
Marketing Category
C73584
G
Generic Name
paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2016
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 Code68083-178
Application NumberANDA207326
Product Classification
M
Marketing Category
C73584
G
Generic Name
paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2016
FDA Product Classification
INGREDIENTS (4)
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PACLITAXELActive
Quantity: 6 mg in 1 mL
Code: P88XT4IS4D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-180
Application NumberANDA207326
Product Classification
M
Marketing Category
C73584
G
Generic Name
paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2016
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