Product Details for ANDA 210327
DOCETAXEL (DOCETAXEL)
20MG/ML (20MG/ML)
Marketing Status: Prescription
80MG/4ML (20MG/ML)
Marketing Status: Prescription
160MG/8ML (20MG/ML)
Marketing Status: Prescription
20MG/ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 001
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOCETAXEL (DOCETAXEL)
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 001
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
80MG/4ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/4ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 002
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOCETAXEL (DOCETAXEL)
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/4ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 002
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
160MG/8ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 160MG/8ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 003
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 160MG/8ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210327
Product Number: 003
Approval Date: May 16, 2019
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information