Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216145

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ZINC SULFATE (ZINC SULFATE MONOHYDRATE)
EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ZINC SULFATE MONOHYDRATE
Proprietary Name: ZINC SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216145
Product Number: 001
Approval Date: Dec 27, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZINC SULFATE (ZINC SULFATE MONOHYDRATE)
EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ZINC SULFATE MONOHYDRATE
Proprietary Name: ZINC SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216145
Product Number: 002
Approval Date: Dec 27, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZINC SULFATE (ZINC SULFATE MONOHYDRATE)
EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ZINC SULFATE MONOHYDRATE
Proprietary Name: ZINC SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216145
Product Number: 003
Approval Date: Dec 27, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information