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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 Meda Pharms 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-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 019618

Tradename:
ROWASA
Applicant:
Meda Pharms
Ingredient:
mesalamine
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:No
Patent:7,645,801Patent 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
Meda Pharms
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 19874,657,900► subscribe
Meda Pharms
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 1987RE33239► subscribe
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