An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
07/30/2024	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019618s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019618Orig1s033ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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
07/30/2024	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019618s033lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf
06/20/2008	SUPPL-18	Labeling-Container/Carton Labels	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

Top