Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206775

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CARBOPLATIN (CARBOPLATIN)
50MG/5ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: CARBOPLATIN
Proprietary Name: CARBOPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206775
Product Number: 001
Approval Date: Feb 9, 2017
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBOPLATIN (CARBOPLATIN)
150MG/15ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: CARBOPLATIN
Proprietary Name: CARBOPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 150MG/15ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206775
Product Number: 002
Approval Date: Feb 9, 2017
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBOPLATIN (CARBOPLATIN)
450MG/45ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: CARBOPLATIN
Proprietary Name: CARBOPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 450MG/45ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206775
Product Number: 003
Approval Date: Feb 9, 2017
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBOPLATIN (CARBOPLATIN)
600MG/60ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: CARBOPLATIN
Proprietary Name: CARBOPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 600MG/60ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A206775
Product Number: 004
Approval Date: Feb 9, 2017
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBOPLATIN (CARBOPLATIN)
1GM/100ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: CARBOPLATIN
Proprietary Name: CARBOPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A206775
Product Number: 005
Approval Date: Apr 6, 2020
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information