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FDA Drug information

Mesalamine

Read time: 1 mins
Marketing start date: 21 Jul 2024

Summary of product characteristics


Effective Time

20221018

Version

6

Spl Product Data Elements

mesalamine mesalamine MESALAMINE MESALAMINE CARBOXYMETHYLCELLULOSE SODIUM CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE TRIETHYL CITRATE BROWN OVAL 711

Application Number

ANDA091640

Brand Name

Mesalamine

Generic Name

mesalamine

Product Ndc

70771-1071

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1071-1 Mesalamine Delayed-release Tablets, 1.2 g Rx only 120 tablets Mesalamine DR Tablets, 1.2 g

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