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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075811
Company: FRESENIUS KABI USA

Products on ANDA 075811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075811

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.html

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.

Labels for ANDA 075811

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

Therapeutic Equivalents for ANDA 075811

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	220518	EUGIA PHARMA
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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