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FDA ANDA · ANDA060569

GRISEOFULVIN MICROSIZE

griseofulvin

Sponsor: CHARTWELL RX

APPLICATION
ANDA060569
TYPE
ANDA
ORIGINAL APPROVAL
1971-09-09
LATEST ACTION
2001-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FULVICIN-U/FPrescription
GRISEOFULVIN, MICROSIZE 500MG · TABLET · ORAL
FULVICIN-U/FPrescription
GRISEOFULVIN, MICROSIZE 250MG · TABLET · ORAL

Approval history

2001-01-26Manufacturing (CMC) · Supplement 7AP
1971-09-09OriginalAP
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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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