Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019618
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROWASA MESALAMINE 4GM/60ML ENEMA;RECTAL Prescription AB Yes Yes
SFROWASA MESALAMINE 4GM/60ML ENEMA;RECTAL Prescription AB Yes 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
12/24/1987 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-23 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019618Orig1s023ltr.pdf
03/24/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/20/2008 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019618s018ltr.pdf
12/29/2005 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019618s016.pdf
07/26/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/2001 SUPPL-13 Labeling

Label is not available on this site.

07/22/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/22/1993 SUPPL-8 Labeling

Label is not available on this site.

02/19/1992 SUPPL-7 Labeling

Label is not available on this site.

03/31/1992 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1991 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1989 SUPPL-2 Labeling

Label is not available on this site.

11/07/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/27/2017 SUPPL-23 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf
07/27/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf
06/20/2008 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf
06/20/2008 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf

ROWASA

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

SFROWASA

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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