Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204029
Company: ABON PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) 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
05/09/2017 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204029Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204029Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204029Orig1s000lbl.pdf

CLOFARABINE

INJECTABLE;IV (INFUSION); 20MG/20ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 204029 ABON PHARMS LLC
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 208857 AMNEAL PHARMS CO
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 205375 DR REDDYS LABS LTD
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 208860 MYLAN LABS LTD
CLOLAR CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 021673 GENZYME

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