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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019884
Company: BAXTER HLTHCARE

Products on NDA 019884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESNEX	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019884

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.

Labels for NDA 019884

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

Therapeutic Equivalents for NDA 019884

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
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	075739	HIKMA
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090913	SAGENT PHARMS INC
MESNEX	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	019884	BAXTER HLTHCARE

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