Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085735
Company: MEDPOINTE PHARM HLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLONAID ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG/5ML;2.5MG/5ML SOLUTION;ORAL Discontinued None 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
02/13/1978 ORIG-1 Approval

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