Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075811
Company: FRESENIUS KABI USA
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
04/26/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75811ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/18/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/05/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

05/13/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna_prntlbl.pdf

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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