Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020292
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FERRISELTZ FERRIC AMMONIUM CITRATE 600MG/PACKET FOR SOLUTION;ORAL Discontinued 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
10/14/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020292.pdf

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