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Queensland Health
Chinese Patent Office
Teva
Citi
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Generated: August 22, 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 five 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-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 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

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)

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 Lp
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
Mylan Speciality Lp
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Covington
Merck
Dow
Johnson and Johnson
Novartis
Colorcon
McKesson
Teva
Cantor Fitzgerald
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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