Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040642
Company: BRECKENRIDGE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET;ORAL Prescription AA No No
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/06/2011 ORIG-1 Approval

Label is not available on this site.

METHSCOPOLAMINE BROMIDE

TABLET;ORAL; 2.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET;ORAL Prescription No AA 200602 BAYSHORE PHARMS LLC
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET;ORAL Prescription No AA 040642 BRECKENRIDGE PHARM

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET;ORAL Prescription No AA 200602 BAYSHORE PHARMS LLC
METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET;ORAL Prescription No AA 040642 BRECKENRIDGE PHARM

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