Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209817
Company: PARATEK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUZYRA OMADACYCLINE TOSYLATE EQ 100MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes 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
10/02/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209816Orig1s000,209817Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209816Orig1s000,209817Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2019 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s004,209817s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s004, 209817Orig1s003ltr.pdf
06/13/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s003,209817s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s003, 209817Orig1s002ltr.pdf
06/13/2019 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s002, 209817Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s004,209817s003lbl.pdf
06/13/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s003,209817s002lbl.pdf
06/13/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf
06/13/2019 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf
10/02/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf

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