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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219632
Company: GLAND PHARMA LIMITED

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 55UG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 0.3MG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 60UG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 3MG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 1000UG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 6UG/1ML INJECTION None (Tentative Approval) None No No
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID 3UG/1ML INJECTION None (Tentative Approval) None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/2025 ORIG-1 Tentative Approval STANDARD

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