Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203554
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTOSTATIN PENTOSTATIN 10MG/VIAL 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
09/19/2014 ORIG-1 Approval

Label is not available on this site.

PENTOSTATIN

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIPENT PENTOSTATIN 10MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020122 HOSPIRA INC
PENTOSTATIN PENTOSTATIN 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 203554 MYLAN INSTITUTIONAL
PENTOSTATIN PENTOSTATIN 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 077841 WEST-WARD PHARMS INT

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