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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216324
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUPRIC SULFATE CUPRIC SULFATE EQ 0.4MG COPPER/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216324Orig1s000ltr.pdf
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