← FDA DRUG APPROVALS

FDA ANDA · ANDA078242

KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN

Sponsor: SUN PHARM INDS INC

APPLICATION
ANDA078242
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-29
LATEST ACTION
2010-08-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TECHNETIUM TC-99M MEBROFENINPrescription
TECHNETIUM TC-99M MEBROFENIN KIT N/A · INJECTABLE · INJECTION

Approval history

2010-08-12Labeling · Supplement 1AP
2008-01-29OriginalLetterAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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