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Details for New Drug Application (NDA): 075547

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NDA 075547 describes THIOTEPA, which is a drug marketed by Teva Parenteral, West-ward Pharms Int, Immunex, and Fresenius Kabi Usa, and is included in four NDAs. It is available from one supplier. Additional details are available on the THIOTEPA profile page.

The generic ingredient in THIOTEPA is thiotepa. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thiotepa profile page.

Summary for NDA: 075547

Tradename:
THIOTEPA
Applicant:
West-ward Pharms Int
Ingredient:
thiotepa
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075547

Mechanism of ActionAlkylating Activity

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 West-Ward Pharmaceuticals Corp 0143-9565 0143-9565-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) > 1.5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/VIAL
Approval Date:Apr 2, 2001TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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