Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085735
Company: MEDPOINTE PHARM HLC
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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