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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020855
Company: BAXTER HLTHCARE

Products on NDA 020855

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESNEX	MESNA	400MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020855

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020855_mesnex.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2018	SUPPL-3	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
03/17/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020855s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf
12/28/2012	SUPPL-1	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020855Orig1s001ltr.pdf

Labels for NDA 020855

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf
12/17/2018	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf
03/17/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020855s002lbl.pdf
03/21/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Prntlbl.pdf

Therapeutic Equivalents for NDA 020855

MESNEX

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESNA	MESNA	400MG	TABLET;ORAL	Prescription	No	AB	218871	NOVAST LABS
MESNEX	MESNA	400MG	TABLET;ORAL	Prescription	Yes	AB	020855	BAXTER HLTHCARE

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