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Generated: December 16, 2017

DrugPatentWatch Database Preview

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 four 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 suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 019618

Tradename:2
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019618

Ingredient-typeAminosalicylic Acids

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 0037-0022-28 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 019618

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality LpROWASAmesalamineENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
Mylan Speciality LpROWASAmesalamineENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
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