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FDA ANDA · ANDA040590

CAFERGOT

ergotamine tartrate and caffeine

Sponsor: MIKART

APPLICATION
ANDA040590
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-16
LATEST ACTION
2024-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERGOTAMINE TARTRATE AND CAFFEINEPrescription
CAFFEINE 100MG, ERGOTAMINE TARTRATE 1MG · TABLET · ORAL

Approval history

2024-06-14Labeling · Supplement 9 · standardAP
2024-06-14Labeling · Supplement 5 · standardAP
2005-09-16OriginalAP
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