Mesalamine
Summary of product characteristics
Effective Time
20221018
Version
5
Spl Product Data Elements
mesalamine mesalamine MESALAMINE MESALAMINE ACETYLTRIBUTYL CITRATE SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL AMMONIA SHELLAC REDDISH-BROWN CAPSULE 435
Application Number
ANDA203286
Brand Name
Mesalamine
Generic Name
mesalamine
Product Ndc
70771-1110
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1110-8 in bottle of 180 tablets Mesalamine Delayed-release Tablets USP, 800 mg R x only 180 tablets Mesalamine Delayed-release Tablets USP, 800 mg
90 mins
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