Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205934

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DOCETAXEL (DOCETAXEL)
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N205934
Product Number: 001
Approval Date: Dec 22, 2015
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DOCETAXEL (DOCETAXEL)
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N205934
Product Number: 002
Approval Date: Dec 22, 2015
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DOCETAXEL (DOCETAXEL)
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N205934
Product Number: 003
Approval Date: Dec 22, 2015
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information