Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076751
Company: PADAGIS ISRAEL

Products on ANDA 076751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	4GM/60ML	ENEMA;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2004	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076751_MesalamineTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2007	SUPPL-6	Labeling		Label is not available on this site.
05/22/2007	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 076751

MESALAMINE

ENEMA;RECTAL; 4GM/60ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESALAMINE	MESALAMINE	4GM/60ML	ENEMA;RECTAL	Prescription	No	AB	216941	ENCUBE
MESALAMINE	MESALAMINE	4GM/60ML	ENEMA;RECTAL	Prescription	No	AB	076751	PADAGIS ISRAEL
ROWASA	MESALAMINE	4GM/60ML	ENEMA;RECTAL	Prescription	Yes	AB	019618	MYLAN SPECIALITY LP
SFROWASA	MESALAMINE	4GM/60ML	ENEMA;RECTAL	Prescription	Yes	AB	019618	MYLAN SPECIALITY LP