An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208264
Company: ADIENNE SA

Products on NDA 208264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEPADINA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	AP	Yes	Yes
TEPADINA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208264s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208264Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208264Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2020	SUPPL-3	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208264Orig1s003Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208264Orig1s003Corrected_ltr.pdf
12/27/2019	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208264Orig1s001ltr.pdf

Labels for NDA 208264

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2020	SUPPL-3	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208264Orig1s003Corrected_lbl.pdf
01/26/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208264s000lbl.pdf

Therapeutic Equivalents for NDA 208264

TEPADINA

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL; 15MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEPADINA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	Yes	AP	208264	ADIENNE SA
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	214222	GLAND PHARMA LTD
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	216037	KINDOS
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	213049	MSN

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEPADINA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	Yes	AP	208264	ADIENNE SA
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	214222	GLAND PHARMA LTD
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	211755	HIKMA
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	216037	KINDOS
THIOTEPA	THIOTEPA	100MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	213049	MSN

Top