Product Details for NDA 215813
DOCIVYX (DOCETAXEL)
20MG/2ML (10MG/ML)
Marketing Status: Prescription
80MG/8ML (10MG/ML)
Marketing Status: Prescription
160MG/16ML (10MG/ML)
Marketing Status: Prescription
20MG/2ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 001
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DOCIVYX (DOCETAXEL)
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 001
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
80MG/8ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 80MG/8ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 002
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DOCIVYX (DOCETAXEL)
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 80MG/8ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 002
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
160MG/16ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 160MG/16ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 003
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DOCIVYX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 160MG/16ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215813
Product Number: 003
Approval Date: Nov 22, 2022
Applicant Holder Full Name: AVYXA HOLDINGS LLC
Marketing Status: Prescription
Patent and Exclusivity Information