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Generated: January 20, 2019

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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 three 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. Twenty-three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019618
Medical Subject Heading (MeSH) Categories for 019618
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 Meda Pharmaceuticals 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 Meda Pharmaceuticals 0037-0022 0037-0022-14 14 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-14) > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ENEMA;RECTALStrength4GM/60ML
Approval Date:Dec 24, 1987TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:ENEMA;RECTALStrength4GM/60ML
Approval Date:Jun 20, 2008TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 24, 2027Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 019618

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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