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FDA ANDA · ANDA200602

METHSCOPOLAMINE BROMIDE

Sponsor: UNICHEM

APPLICATION
ANDA200602
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-24
LATEST ACTION
2019-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METHSCOPOLAMINE BROMIDEPrescription
METHSCOPOLAMINE BROMIDE 2.5MG · TABLET · ORAL
METHSCOPOLAMINE BROMIDEPrescription
METHSCOPOLAMINE BROMIDE 5MG · TABLET · ORAL

Approval history

2019-04-23Manufacturing (CMC) · Supplement 5 · unknownAP
2012-09-24Not Applicable · OriginalAP
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