Details for New Drug Application (NDA): 211755
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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.
Pharmacology for NDA: 211755
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 211755
Suppliers and Packaging for NDA: 211755
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 211755 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9292 | 0143-9292-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 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 | 100MG/VIAL | ||||
Approval Date: | Sep 5, 2023 | TE: | AP | RLD: | No |
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