Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076571
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION 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
04/22/2004 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
09/29/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

CLADRIBINE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 076571 FRESENIUS KABI USA
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 210856 HISUN PHARM HANGZHOU
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 200510 MYLAN LABS LTD
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075405 WEST-WARD PHARMS INT

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