Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 212034
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;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
02/22/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CLOFARABINE

SOLUTION;INTRAVENOUS; 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) SOLUTION;INTRAVENOUS Prescription No AP 204029 ABON PHARMS LLC
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212034 ACCORD HLTHCARE
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208857 AMNEAL PHARMS CO
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205375 DR REDDYS LABS LTD
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207831 GLAND PHARMA LTD
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210270 INGENUS PHARMS LLC
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209775 MSN LABS PVT LTD
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208860 MYLAN LABS LTD
CLOLAR CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 021673 GENZYME

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