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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207518
Company: SHILPA MEDICARE

Products on ANDA 207518

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 207518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/23/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/23/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/06/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/25/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207518

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	215765	HETERO LABS LTD VI
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	217453	RELIANCE LIFE
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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