Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208264
Company: ADIENNE SA
Company: ADIENNE SA
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 |
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 |
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 |
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 |