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FDA Drug information

IBUPROFEN

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


Effective Time

20201115

Version

1

Spl Product Data Elements

IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 122

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

45865-117

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PDP 600 mg PDP 600 mg

Spl Medguide

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide MEDGUIDE IBUPROFEN TABLETS

How Supplied

HOW SUPPLIED 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

Drug section

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