Details for New Drug Application (NDA): 214222
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NDA 214222 describes THIOTEPA, which is a drug marketed by Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Teva Parenteral, West-ward Pharms Int, Gland Pharma Ltd, Hikma, Meitheal, and MSN, and is included in thirteen NDAs. It is available from eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 214222
| Tradename: | THIOTEPA |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | thiotepa |
| Patents: | 0 |
Pharmacology for NDA: 214222
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 214222
Suppliers and Packaging for NDA: 214222
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 214222 | ANDA | Dr.Reddy's Laboratories Inc., | 43598-171 | 43598-171-11 | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 214222 | ANDA | Fresenius Kabi USA, LLC | 65219-029 | 65219-029-20 | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Strength | 15MG/VIAL | ||||
| Approval Date: | Mar 8, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Strength | 100MG/VIAL | ||||
| Approval Date: | Jan 3, 2022 | TE: | AP | RLD: | No | ||||
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