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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215636

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METHYLENE BLUE (METHYLENE BLUE)
10MG/2ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: METHYLENE BLUE
Proprietary Name: METHYLENE BLUE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215636
Product Number: 001
Approval Date: Dec 5, 2023
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLENE BLUE (METHYLENE BLUE)
50MG/10ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: METHYLENE BLUE
Proprietary Name: METHYLENE BLUE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215636
Product Number: 002
Approval Date: Dec 5, 2023
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information
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