Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077126
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIFOSTINE AMIFOSTINE 500MG/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
03/14/2008 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
02/04/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

AMIFOSTINE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIFOSTINE AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204363 MYLAN LABS LTD
AMIFOSTINE AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 077126 SUN PHARMA GLOBAL
ETHYOL AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020221 CLINIGEN HLTHCARE

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