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Mesalamine

These highlights do not include all the information needed to use Mesalamine safely and effectively. See full prescribing information for Mesalamine . M esalamine suppositor ies, for rectal use Initial U.S. Approval: 1987

Approved
Approval ID

3ef5c3f6-587e-48ea-a4b4-a7bf1bd749c6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers
FDA

Greenstone LLC

DUNS: 825560733

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

mesalamine

PRODUCT DETAILS

NDC Product Code59762-0118
Application NumberNDA021252
Marketing CategoryC73605
Route of AdministrationRECTAL
Effective DateDecember 27, 2023
Generic Namemesalamine

INGREDIENTS (2)

MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
HARD FATInactive
Code: 8334LX7S21
Classification: IACT

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Mesalamine - FDA Drug Approval Details