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FDA Drug information

Mesalamine

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221018

Version

2

Spl Product Data Elements

Mesalamine Mesalamine MESALAMINE MESALAMINE ETHYLCELLULOSE (10 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) TALC TRIETHYL CITRATE FD&C BLUE NO. 1 GELATIN WATER SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SUCROSE STARCH, CORN opaque blue cap opaque blue body 452

Application Number

ANDA208954

Brand Name

Mesalamine

Generic Name

Mesalamine

Product Ndc

70771-1625

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Mesalamine Extended-Release Capsules, 0.375 g 120 capsules NDC 70771-1625-7 Rx only mfg label

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Disclaimer

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