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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209817
Company: PARATEK PHARMS INC

Products on NDA 209817

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209817

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
01/11/2021	SUPPL-11	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s012; 209817Orig1s011ltr.pdf
05/27/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209816s011,209817s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209816Orig1s011; 209817Orig1s010ltr.pdf
10/20/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209816s009,209817s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s009, 209817Orig1s008ltr.pdf
09/02/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/219816s008,209817s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s008, 209817Orig1s007ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 209817

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209816s011,209817s010lbl.pdf
10/20/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209816s009,209817s008lbl.pdf
09/02/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/219816s008,209817s007lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf
06/13/2019	SUPPL-1	Labeling-Package Insert	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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