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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203475
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/27/2017 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
09/29/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/29/2021 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/29/2021 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 INC
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
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