Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075739
Company: HIKMA

Products on ANDA 075739

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
MESNA	MESNA	1G/10ML	Injectable; Injection	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075739

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2024	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
07/17/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/17/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075739

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