Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202969
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/28/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202969Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2017 SUPPL-1 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
DACOGEN DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021790 OTSUKA PHARM CO LTD
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 208601 CIPLA
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 203131 DR REDDYS
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210984 INGENUS PHARMS LLC
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210756 LUPIN LTD
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 212265 MSN LABS PVT LTD
DECITABINE DECITABINE 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 204607 PHARMASCIENCE INC
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

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