← FDA Drug Approvals (Drugs@FDA)

THIOTEPA

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2023-09-05

Drug application

FDA Application #
ANDA211755
Application type
Abbreviated New Drug Application (Generic)
Brand name
THIOTEPA
Generic name
THIOTEPA
Active ingredients
THIOTEPA
Dosage form
POWDER
Route
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Marketing status
Prescription
Sponsor
HIKMA
Manufacturer
Hikma Pharmaceuticals USA Inc.
First approval
2023-09-05

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown