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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019618
Company: MYLAN SPECIALITY LP

Products on NDA 019618

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019618

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
10/24/2023	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019618s032lbl.pdf
11/16/2022	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019618s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019618Orig1s030ltr.pdf
11/01/2021	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019618Orig1s029ltr.pdf
06/25/2021	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019618Orig1s027ltr.pdf
10/01/2020	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019618s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019618Orig1s026ltr.pdf
07/27/2017	SUPPL-23	Labeling-Package Insert, Labeling-Patient 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.

Labels for NDA 019618

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019618s032lbl.pdf
11/16/2022	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019618s030lbl.pdf
11/01/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s029lbl.pdf
06/25/2021	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s027lbl.pdf
10/01/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019618s026lbl.pdf
07/27/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf
07/27/2017	SUPPL-23	Labeling-Patient 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

Therapeutic Equivalents for NDA 019618

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	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

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	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

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