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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050744
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERIOSTAT DOXYCYCLINE HYCLATE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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
09/30/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50744lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50744ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50744.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50744lbl.pdf
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