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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201537
Company: DR REDDYS

Products on ANDA 201537

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 ANDA 201537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2013	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201537Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/09/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/28/2017	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/28/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/28/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201537

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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