NDC 72205-046
Thiotepa
Thiotepa
Thiotepa is a Intracavitary; Intravenous; Intravesical Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novadoz Pharmaceuticals Llc. The primary component is Thiotepa.
| Product ID | 72205-046_b702dcc9-dd0e-4386-b1e2-f20562fd2ad9 |
| NDC | 72205-046 |
| 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 | 2020-02-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA213049 |
| Labeler Name | Novadoz Pharmaceuticals LLC |
| Substance Name | THIOTEPA |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 72205-046-01
1 VIAL, GLASS in 1 BOX (72205-046-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
| Marketing Start Date | 2020-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 72205-046-01 [72205004601]
Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA213049 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-02-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| THIOTEPA | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | b702dcc9-dd0e-4386-b1e2-f20562fd2ad9 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Alkylating Activity [MoA]
- Alkylating Drug [EPC]
NDC Crossover Matching brand name "Thiotepa" or generic name "Thiotepa"
| 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 |
Trademark Results [Thiotepa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THIOTEPA 73471323 not registered Dead/Abandoned |
AMERICAN CYANAMID COMPANY 1984-03-21 |
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