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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205582
Company: SUN PHARM

Summary Review

Products on NDA 205582

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECITABINE	DECITABINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205582Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2020	SUPPL-15	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s015ltr.pdf
05/21/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s014ltr.pdf
02/03/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205582Orig1s012ltr.pdf
05/22/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205582s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205582Orig1s009ltr.pdf
03/16/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/14/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205582

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2020	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
09/16/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
05/21/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s014lbl.pdf
02/03/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s012lbl.pdf
05/22/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205582s009lbl.pdf
01/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf

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