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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208216
Company: ACTAVIS LLC

Products on NDA 208216

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208216s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208216Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208216Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208216s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208216Orig1s006ltr.pdf
07/13/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208216s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208216Orig1s005ltr.pdf
10/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208216s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208216Orig1s002ltr.pdf
01/10/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208216s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208216Orig1s001ltr.pdf

Labels for NDA 208216

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208216s006lbl.pdf
07/13/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208216s005lbl.pdf
10/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208216s002lbl.pdf
01/10/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208216s001lbl.pdf
04/29/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208216s000lbl.pdf

Therapeutic Equivalents for NDA 208216

AZACITIDINE

POWDER;INTRAVENOUS, SUBCUTANEOUS; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207475	ACCORD HLTHCARE
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	208216	ACTAVIS LLC
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211549	AMNEAL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209540	CIPLA
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	201537	DR REDDYS
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	215066	EUGIA PHARMA
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209337	EUROHLTH INTL SARL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	215905	JIANGSU HANSOH PHARM
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212128	MEITHEAL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212580	MSN LABS PVT LTD
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207234	NATCO PHARMA LTD
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207518	SHILPA MEDICARE
VIDAZA	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	050794	BRISTOL-MYERS

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