Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209634

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DOCETAXEL (DOCETAXEL)
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: A209634
Product Number: 001
Approval Date: Aug 24, 2018
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOCETAXEL (DOCETAXEL)
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: A209634
Product Number: 002
Approval Date: Aug 24, 2018
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOCETAXEL (DOCETAXEL)
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: A209634
Product Number: 003
Approval Date: Aug 24, 2018
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information