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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213917

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MAGNESIUM SULFATE IN PLASTIC CONTAINER (MAGNESIUM SULFATE)
2GM/50ML (40MG/ML)
Marketing Status: Prescription
Active Ingredient: MAGNESIUM SULFATE
Proprietary Name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/50ML (40MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213917
Product Number: 001
Approval Date: Jul 10, 2020
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
MAGNESIUM SULFATE IN PLASTIC CONTAINER (MAGNESIUM SULFATE)
4GM/100ML (40MG/ML)
Marketing Status: Prescription
Active Ingredient: MAGNESIUM SULFATE
Proprietary Name: MAGNESIUM SULFATE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4GM/100ML (40MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213917
Product Number: 002
Approval Date: Jul 10, 2020
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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