Thiotepa is a Intracavitary; Intravenous; Intravesical Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Thiotepa.
Product ID | 68083-446_283f8e9e-6f72-4e0b-9459-e7d4430ad0ee |
NDC | 68083-446 |
Product Type | Human Prescription Drug |
Proprietary Name | Thiotepa |
Generic Name | Thiotepa |
Dosage Form | Injection, Powder, Lyophilized, For Solution |
Route of Administration | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
Marketing Start Date | 2021-03-08 |
Marketing Category | ANDA / |
Application Number | ANDA214222 |
Labeler Name | Gland Pharma Limited |
Substance Name | THIOTEPA |
Active Ingredient Strength | 15 mg/1 |
Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2021-03-08 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0143-9309 | Thiotepa | Thiotepa |
0143-9565 | Thiotepa | Thiotepa |
25021-246 | Thiotepa | Thiotepa |
43598-171 | Thiotepa | Thiotepa |
43598-650 | Thiotepa | Thiotepa |
54879-014 | Thiotepa | Thiotepa |
65219-029 | Thiotepa | Thiotepa |
68083-446 | Thiotepa | Thiotepa |
68083-503 | Thiotepa | Thiotepa |
69539-123 | Thiotepa | Thiotepa |
69539-124 | Thiotepa | Thiotepa |
70860-220 | Thiotepa | thiotepa |
72205-045 | Thiotepa | Thiotepa |
72205-046 | Thiotepa | Thiotepa |
53964-001 | TEPADINA | THIOTEPA |
53964-002 | TEPADINA | THIOTEPA |
70121-1630 | TEPADINA | THIOTEPA |
70121-1631 | TEPADINA | THIOTEPA |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THIOTEPA 73471323 not registered Dead/Abandoned |
AMERICAN CYANAMID COMPANY 1984-03-21 |