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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203585
Company: TEVA PHARMS INTL

Medication Guide

Summary Review

Products on NDA 203585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNRIBO	OMACETAXINE MEPESUCCINATE	3.5MG/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203585lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203585Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203585Orig1s008ltr.pdf
11/26/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203585s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203585Orig1s007ltr.pdf
01/23/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203585s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203585Orig1s006ltr.pdf
06/21/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203585s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203585Orig1s005ltr.pdf
06/13/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203585s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203585Orig1s004ltr.pdf
05/01/2014	SUPPL-3	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s003ltr.pdf
11/22/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/10/2014	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s001ltr.pdf

Labels for NDA 203585

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2021	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf
05/12/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf
05/12/2021	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf
05/12/2021	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf
11/26/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203585s007lbl.pdf
01/23/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203585s006lbl.pdf
06/21/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203585s005lbl.pdf
06/13/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203585s004lbl.pdf
05/01/2014	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s003lbl.pdf
02/10/2014	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s001lbl.pdf
10/26/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203585lbl.pdf

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