Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076657
Company: MEITHEAL

Products on ANDA 076657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IFOSFAMIDE	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes
IFOSFAMIDE	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2007	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
12/22/2020	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/14/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
06/13/2014	SUPPL-3	Labeling		Label is not available on this site.

Labels for ANDA 076657

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf
05/14/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf

Therapeutic Equivalents for ANDA 076657

IFOSFAMIDE

INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IFOSFAMIDE	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076619	HIKMA
IFOSFAMIDE	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076657	MEITHEAL

INJECTABLE;INJECTION; 3GM/60ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IFOSFAMIDE	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076619	HIKMA
IFOSFAMIDE	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076657	MEITHEAL