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Details for New Drug Application (NDA): 209150
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NDA 209150 describes THIOTEPA, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Immunex, Jiangsu Hengrui Med, Teva Parenteral, and West-ward Pharms Int, and is included in six NDAs. It is available from three suppliers. Additional details are available on the THIOTEPA profile page.
The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 209150
| Tradename: | THIOTEPA |
| Applicant: | Jiangsu Hengrui Med |
| Ingredient: | thiotepa |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209150
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 209150
Suppliers and Packaging for NDA: 209150
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOTEPA | thiotepa | INJECTABLE;INJECTION | 209150 | ANDA | Sagent Pharmaceuticals | 25021-246 | 25021-246-02 | 1 VIAL in 1 CARTON (25021-246-02) > 1.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/VIAL | ||||
| Approval Date: | May 4, 2018 | TE: | AP | RLD: | No | ||||
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