Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019884
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESNEX MESNA 100MG/ML INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/2018 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019884Orig1s016, 020855Orig1s003ltr.pdf
02/26/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/17/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf
01/30/2003 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf
01/30/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf
07/26/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1995 SUPPL-5 Labeling

Label is not available on this site.

05/23/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/16/1994 SUPPL-2 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
12/17/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf
12/17/2018 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf
03/17/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf

MESNEX

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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