Details for New Drug Application (NDA): 075547
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NDA 075547 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 075547
| Tradename: | THIOTEPA |
| Applicant: | West-ward Pharms Int |
| Ingredient: | thiotepa |
| Patents: | 0 |
Pharmacology for NDA: 075547
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 075547
Suppliers and Packaging for NDA: 075547
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOTEPA | thiotepa | INJECTABLE;INJECTION | 075547 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9309 | 0143-9309-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| THIOTEPA | thiotepa | INJECTABLE;INJECTION | 075547 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9565 | 0143-9565-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/VIAL | ||||
| Approval Date: | Apr 2, 2001 | TE: | AP | RLD: | No | ||||
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