Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090913
Company: SAGENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESNA MESNA 100MG/ML INJECTABLE;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
04/13/2010 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
08/21/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

MESNA

INJECTABLE;INTRAVENOUS; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESNA MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription No AP 075811 FRESENIUS KABI USA
MESNA MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription No AP 206992 GLAND PHARMA LTD
MESNA MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription No AP 090913 SAGENT PHARMS INC
MESNA MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription No AP 075739 WEST-WARD PHARMS INT
MESNEX MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription Yes AP 019884 BAXTER HLTHCARE

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