Product Details for ANDA 075730
THIOTEPA (THIOTEPA)
15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: THIOTEPA
Proprietary Name: THIOTEPA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075730
Product Number: 001
Approval Date: Apr 20, 2001
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
THIOTEPA (THIOTEPA)
Proprietary Name: THIOTEPA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075730
Product Number: 001
Approval Date: Apr 20, 2001
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: THIOTEPA
Proprietary Name: THIOTEPA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075730
Product Number: 002
Approval Date: Apr 20, 2001
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: THIOTEPA
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075730
Product Number: 002
Approval Date: Apr 20, 2001
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status: Discontinued
Patent and Exclusivity Information