Product Details for NDA 208574
ROMIDEPSIN (ROMIDEPSIN)
10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROMIDEPSIN
Proprietary Name: ROMIDEPSIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208574
Product Number: 001
Approval Date: Mar 13, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ROMIDEPSIN (ROMIDEPSIN)
Proprietary Name: ROMIDEPSIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208574
Product Number: 001
Approval Date: Mar 13, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROMIDEPSIN
Proprietary Name: ROMIDEPSIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208574
Product Number: 002
Approval Date: Mar 13, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ROMIDEPSIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208574
Product Number: 002
Approval Date: Mar 13, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information