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FDA ANDA · ANDA091592

GRISEOFULVIN

Sponsor: SANDOZ

APPLICATION
ANDA091592
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-07
LATEST ACTION
2013-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GRISEOFULVINPrescription
GRISEOFULVIN, MICROSIZE 250MG · TABLET · ORAL
GRISEOFULVINPrescription
GRISEOFULVIN, MICROSIZE 500MG · TABLET · ORAL

Approval history

2013-08-07Not Applicable · OriginalAP
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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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