Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203131
Company: DR REDDYS

Products on ANDA 203131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/10/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/03/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203131

DECITABINE

INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203475	ACCORD HLTHCARE
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206033	CHEMI SPA
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203131	DR REDDYS
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214569	EUGIA PHARMA
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205539	GLAND
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213472	JIANGSU HANSOH PHARM
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210756	LUPIN LTD
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	212959	MEITHEAL
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	212265	MSN
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	212117	NIVAGEN PHARMS INC
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210984	NOVAST LABS
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204607	PHARMASCIENCE INC
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	212826	QILU PHARM HAINAN
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207100	SAGENT PHARMS INC
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202969	SANDOZ
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209056	WOCKHARDT BIO AG
DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214486	ZYDUS PHARMS