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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 019618

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NDA 019618 describes SFROWASA, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the SFROWASA profile page.

The generic ingredient in SFROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 019618

Tradename:	SFROWASA
Applicant:	Mylan Speciality Lp
Ingredient:	mesalamine
Patents:	1

Pharmacology for NDA: 019618

Medical Subject Heading (MeSH) Categories for 019618

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 019618

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROWASA	mesalamine	ENEMA;RECTAL	019618	NDA	Viatris Specialty LLC	0037-0022	0037-0022-07	7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
ROWASA	mesalamine	ENEMA;RECTAL	019618	NDA	Viatris Specialty LLC	0037-0022	0037-0022-28	28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ENEMA;RECTAL			Strength	4GM/60ML
Approval Date:	Dec 24, 1987	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	ENEMA;RECTAL			Strength	4GM/60ML
Approval Date:	Jun 20, 2008	TE:	AB	RLD:	Yes
Patent:	7,645,801	Patent Expiration:	Jul 24, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 019618

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	4,657,900	⤷ Get Started Free
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	RE33239	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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