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FDA Drug information

Imatinib mesylate

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


Effective Time

20221013

Version

2

Spl Product Data Elements

imatinib mesylate imatinib mesylate IMATINIB MESYLATE IMATINIB CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE MANNITOL POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE PALE YELLOW TO YELLOW ROUND 244 imatinib mesylate imatinib mesylate IMATINIB MESYLATE IMATINIB CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE MANNITOL POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE PALE YELLOW TO YELLOW ovaloid 245

Application Number

ANDA210658

Brand Name

Imatinib mesylate

Generic Name

imatinib mesylate

Product Ndc

70771-1395

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1394-9 Imatinib Mesylate Tablets, 100 mg 90 Tablets Rx only NDC 70771-1395-9 Imatinib Mesylate Tablets, 400 mg 90 Tablets Rx only 100 mg 400 mg

Drug section

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