Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200510
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION 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
10/06/2011 ORIG-1 Approval Not Applicable

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 200510 MYLAN LABS LTD
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075405 WEST-WARD PHARMS INT

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