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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205654


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NDA 205654 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alkem Labs Ltd, Mylan, Zydus Pharms, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Aptapharma Inc, Sandoz Inc, Actavis Labs Fl, and Sun Pharm, and is included in nineteen NDAs. It is available from twenty-one suppliers. Additional details are available on the MESALAMINE profile page.

The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 205654
Tradename:MESALAMINE
Applicant:Actavis Mid Atlantic
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205654
Medical Subject Heading (MeSH) Categories for 205654
Suppliers and Packaging for NDA: 205654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine SUPPOSITORY;RECTAL 205654 ANDA Actavis Pharma, Inc. 0472-1915 0472-1915-30 30 POUCH in 1 BOX (0472-1915-30) > 1 SUPPOSITORY in 1 POUCH (0472-1915-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength1GM
Approval Date:Aug 14, 2020TE:ABRLD:No

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