U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213461
Company: MEITHEAL

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
10/23/2020 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2023 SUPPL-2 Labeling-Package Insert

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
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205375 DR REDDYS
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 213461 MEITHEAL
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209775 MSN
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
Back to Top