Thiotepa
Thiotepa for Injection
Approved
Approval ID
0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2018
Manufacturers
FDA
Dr.Reddy's Laboratories Inc.,
DUNS: 802315887
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Thiotepa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-650
Application NumberANDA210337
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAVESICAL, INTRACAVITARY
Effective DateSeptember 21, 2017
FDA Product Classification
INGREDIENTS (2)
ThiotepaActive
Quantity: 15 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT