Product Details for ANDA 215744
DOCETAXEL (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: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 001
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOCETAXEL (DOCETAXEL)
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 001
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
80MG/8ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/8ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 002
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOCETAXEL (DOCETAXEL)
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/8ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 002
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
160MG/16ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DOCETAXEL
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 160MG/16ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 003
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DOCETAXEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 160MG/16ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215744
Product Number: 003
Approval Date: Feb 28, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information