Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076751
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESALAMINE MESALAMINE 4GM/60ML ENEMA;RECTAL Prescription AB No No
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.

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 076751 PERRIGO 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

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