Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214222
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THIOTEPA | THIOTEPA | 15MG/VIAL | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Prescription | AP | No | No |
THIOTEPA | THIOTEPA | 100MG/VIAL | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/08/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
THIOTEPA
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 |